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1.  Half versus full vacuum suction drainage after modified radical mastectomy for breast cancer- a prospective randomized clinical trial[ISRCTN24484328] 
BMC Cancer  2005;5:11.
Suction drains are routinely used after modified radical mastectomy and are an important factor contributing to increased hospital stay as the patients are often discharged only after their removal. Amongst various factors that influence the amount of postoperative drainage, the negative suction pressure applied to the drain has been reported to be of great significance. While a high negative suction pressure is expected to drain the collection and reduce the dead space promptly, it may also prevent the leaking lymphatics from closing and lead to increased drainage from the wound. Against this background a prospective randomized clinical study was conducted to compare the amount and duration of drainage between a half negative suction and full vacuum suction drainage in patients following modified radical mastectomy. The associated postoperative morbidity was also compared between the two groups.
85 FNAC (fine needle aspiration cytology) proven cases of locally advanced breast cancer were randomized. (Using randomly ordered sealed envelops, which were opened immediately before the closure of the wound) in to 50 patients with full vacuum suction (pressure = 700 g/m2) and 35 cases in to half vacuum suction drainage (pressure = 350 g/m2) groups. The two groups were comparable in respect of age, weight, and technique of operation and extent of axillary dissection. Surgery was performed by the same surgical team comprising of five surgeons (two senior and three resident surgeons) using a standardized technique with electrocautery. External compression dressing was provided over the axilla for first 48 hrs and following that patients were encouraged to do active and passive shoulder exercises. The outcomes measured were postoperative morbidity and the length of hospital stay.
Statistical methods used: Descriptive studies were performed with SPSS version 10 and group characteristics were compared using student t-test.
Half vacuum suction drains were removed earlier than the full suction vacuum suction drains. There was no significant difference in the incidence of seroma formation in the two groups and there was a significant reduction in the total hospital stay in patients with half vacuum suction drainage systems as compared to the full suction drainage group (p < 0.001) without any added morbidity.
Half negative suction drains provide an effective compromise between no suction and full or high suction drainage after modified radical mastectomy by reducing the hospital stay and the post operative morbidity including post operative seromas.
PMCID: PMC548268  PMID: 15676064
2.  The use of fibrin sealant after total thyroidectomy for benign disease obviates the need for routine drainage. Results of a randomized controlled trial 
Hippokratia  2011;15(3):247-251.
Background: Drains are usually left after thyroid surgery to prevent formation of hematoma and seroma in the thyroid bed. This prospective randomized clinical trial was conducted to evaluate the necessity of drainage after total thyroidectomy for benign thyroidal disorders.
Methods: The patients were assigned randomly into two groups (group 1: with suction drain, group 2: fibrin glue). In the study, operating time, postoperative pain, the total amount of intramuscular analgesic administration, hospital stay, complications (such as wound infection, seroma, bleeding, hematoma, recurrent laryngeal nerve palsy or hypoparathyroidism), were recorded.
Results: The drained group (group 1) consisted of 2 men and 48 women with a mean age of 47.76±11.22 years. The nondrained (plus fibrin sealant)( group 2) (comprised of 10 men and 40 women with a mean age of 44.72±11.32 years. There was no significant difference in the gender, age, hormonal status and histopathological results of the patients between the two groups (P=0.18, P=0.36, P=0.28 and P=0.40, respectively). The operations performed were total thyroidectomy in all patients. Twenty-five patients (50%) in the non-drained group did not need intramuscular analgesic, whereas 15 patients (30%) did not in the drained group (P=0.01). In addition, the mean amount of intramuscular analgesic requirement was significantly less in the non-drained group than in the drained group (P=0.02). The complication rates were similar between the two groups. One case of hematoma (2%), two cases of seroma (4%) and three cases of transient hypoparathyroidism (6%) occurred in the non-drained group, whereas one case of hematoma (2%), two cases of seroma (4%), two cases of wound infections (4%) and two cases of transient hypoparathyroidism (4%) occurred in the drained group (P=0.69). No patient needed surgical revision or re-operation for any complication and all complications were successfully managed conservatively.
Conclusion: Routine drainage of thyroid bed following thyroid surgery may not be necessary. Not draining the wound results in lesser morbidity and decreased hospital stay.
PMCID: PMC3306032  PMID: 22435023
thyroidectomy; drainage; complications; fibrin sealant
3.  An analysis of quantitative measurements of drainage exudate using negative suction in 96 microtia ear reconstructions 
Negative suction drainage is commonly used for the prevention of seromas or hematomas in auricular reconstruction surgery; however, there are few reports regarding the quantitative measurement of negative suction and its relation to disposed time, patient age or microtia type. In the present study, the authors recorded the volume of suction exudate in microtia reconstruction and elaborate on the relevant details of controlling negative suction. A negative suction drainage system was applied in 96 microtia patients between 2007 and 2010. Two small polyethylene drains were inserted adjacent to the concha and the scapha, respectively. The volume of exudate was recorded for three days after surgery and was analyzed according to disposed time, patient age and microtia type. The drains were removed on the third postoperative day, when only a small amount of exudate remained. A significant change in drainage was observed over three days postoperatively, and the quantity decreased progressively on the third postoperative day. Comparison of age groups showed that the volume of drainage from adults was greater than that from children or adolescents in the first two postoperative days, regardless of whether the drains were inserted in the scapha or concha. No statistical differences were found on the third postoperative day. A comparison of drain types revealed no statistically significant differences between scapha and concha drains three days postoperatively. The analysis demonstrated that drainage quantity is related to disposed time and patient age, but not to microtia type. The authors recommend removal of suction drains on the third postoperative day. Moreover, individualized negative suction treatment according to age or microtia type provides a safe and consistent approach to achieving acceptable results and fewer complications.
PMCID: PMC3513248  PMID: 24294013
Ear reconstruction; Microtia; Negative suction; Quantity measurement
4.  Outcome in primary cemented total knee arthroplasty with or without drain: A prospective comparative study 
Indian Journal of Orthopaedics  2014;48(4):404-409.
Suction drain insertion is a common practice in orthopedic surgery, especially after joint arthroplasty to prevent the formation of a hematoma. Theoretically the use of a drain should diminish the volume of hematoma; however the literature has conflicting data. Some authors state that drainage evacuates fluid from a limited area only and can be a cause of infection due to retrograde migration of bacteria. It can also impair the early postoperative rehabilitation. The aim of this study was to evaluate the clinical outcome (especially postoperative pain) and intake of analgesics in patients who had undergone primary cemented total knee arthroplasty (TKA) with or without a postoperative drain.
Materials and Methods:
A prospective comparative study of 108 consecutive patients (121 knees) was conducted. They were divided into two groups: A study group, with no drainage and a control group with drain inserted at the end of surgery. A total of 121 patients were recruited into two groups. A study group consisted of 59 knees, in which we did not use drainage after TKA and a control group with 62 knees, in which drain was inserted post surgery. Both groups were comparable in terms of preoperative characteristics. The indication for TKA was osteoarthritis (n = 105) and rheumatoid arthritis (n = 16).
In patients without drainage we observed lower need for opioids, higher blood loss on the 1st postoperative day and a lower need for change of dressings. There were no statistically significant differences in terms of total blood loss, hidden blood loss, transfusion rate, range of motion, length of hospital stay or incidence of complications between the two groups. In 1 year observation there were no differences in clinical outcome between the two groups.
The present study conclude that there is no rationale for the use of drain after primary TKA. There are benefits in terms of lower opioid intake, lower blood loss on the first postoperative day and lower need for dressing reinforcement during hospitalization.
PMCID: PMC4137520  PMID: 25143646
Blood loss; drain; dressing reinforcement; opioids; total knee arthroplasty; Arthroplasty; replacement; knee; blood loss; surgical drainage suction
5.  Subcutaneous versus Intraarticular Indwelling Closed Suction Drainage after TKA: A Randomized Controlled Trial 
TKA can involve substantial bleeding, and the issue regarding whether vacuum drainage should be used during TKA continues to be debated as both methods have disadvantages.
We therefore asked whether subcutaneous indwelling vacuum drainage is advantageous over intraarticular indwelling vacuum drainage in terms of blood drainage, bleeding-related complications, and functional outcomes in primary TKA.
Patients and methods
We randomized 111 patients undergoing TKAs to have either a subcutaneous indwelling or an intraarticular indwelling catheter and compared the two groups for blood loss (hemoglobin decrease, transfusion requirements, hypotension episode), incidence of wound problems (requirements for dressing reinforcement, oozing, hematoma, hemarthrosis, ecchymosis, infection), and functional outcomes (recovery of motion arc, American Knee Society, WOMAC, and SF-36 scores) at 12 months after surgery.
The mean vacuum drainage volume was less in the subcutaneous indwelling group than in the intraarticular indwelling group (140 mL versus 352 mL). The groups were similar in terms of decreases in hemoglobin after 2 and 5 days (3.0 versus 3.3 g/dL and 3.3 versus 3.7 g/dL, respectively), allogenic transfusion requirements (4% versus 11%), incidence of wound problems, and functional scores.
The data suggest subcutaneous indwelling closed-suction drainage is a reasonable alternative to intraarticular indwelling closed-suction drainage and to no suction drainage.
Level of Evidence
Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
PMCID: PMC2895852  PMID: 20127212
6.  Case Report: Cauda Equina Syndrome Associated With an Interspinous Device 
Although postoperative spinal epidural hematoma (SEH) is not uncommon, hematomas that require surgery are rare. Cauda equina syndrome (CES) may be associated with postoperative SEH. In these cases, early recognition and emergency decompression can prevent further damage and better neurologic recovery.
Case Description
A 41-year-old man underwent two-level discectomy with insertion of an interspinous spacer at L3-4 and L4-5 because of low back pain and radiculopathy. Eight hours after the operation, the patient developed CES. MRI revealed SEH compressing posteriorly at the L3-4 level. On emergency decompression and hematoma evacuation, the interspinous spacer had obstructed the laminotomy site at L3-4 completely, blocking drainage to the drain. The patient experienced complete neurologic recovery by 2 months followup.
Literature Review
Many studies report risk factors for SEH. However, postoperative SEH can also be encountered in patients without these risks. One study reported a critical ratio (preoperative versus postoperative cross-sectional area) correlated with postoperative symptoms, especially in those with CES. The propensity to develop CES is likely dependent on a number of patient-specific factors.
Clinical Relevance
Surgeons should be aware that patients without risk factors may develop acute CES. Wider laminotomy (larger than half of the device size) may help to prevent this complication when one uses the compressible type of device, especially in patients with relatively small lamina.
PMCID: PMC3348300  PMID: 21870210
7.  Postoperative Spinal Epidural Hematoma: Risk Factor and Clinical Outcome 
Yonsei Medical Journal  2006;47(3):326-332.
We report a series of epidural hematomas which cause neurologic deterioration after spinal surgery, and have taken risk factors and prognostic factors into consideration. We retrospectively reviewed the database of 3720 cases of spine operation in a single institute over 7 years (1998 April-2005 July). Nine patients who demonstrated neurologic deterioration after surgery and required surgical decompression were identified. Factors postulated to increase the postoperative epidural hematoma and to improve neurologic outcome were investigated. The incidence of postoperative epidural hematoma was 0.24%. Operation sites were cervical 3 cases, thoracic 2 cases, and lumbar 4 cases. Their original diagnoses were tumor 3 cases, cervical stenosis 2 cases, lumbar stenosis 3 cases and herniated lumbar disc 1case. The symptoms of epidural hematomas were neurologic deterioration and pain. After decompression, clinical outcome revealed complete recovery in 3 cases (33.3%), incomplete recovery in 5 cases (55.6%) and no change in 1 case (11.1%). Factors increasing the risk of postoperative epidural hematoma were coagulopathy from medical illness or anticoagulation therapy (4 cases, 44.4%) and highly vascularized tumor (3 cases, 33.3%). The time interval to evacuation of complete recovery group (29.3 hours) was shorter than incomplete recovery group (66.3 hours). Patients with coagulopathy and highly vascularized tumor were more vulnerable to spinal epidural hematoma. The postoperative outcome was related to the preoperative neurological deficit and the time interval to the decompression.
PMCID: PMC2688151  PMID: 16807981
Clinical outcome; risk factor; postoperative; spinal epidural hematoma; spine surgery
8.  Effectiveness of Postoperative Wound Drains in One- and Two-Level Cervical Spine Fusions 
Cervical drains have historically been used to avoid postoperative wound and respiratory complications such as excessive edema, hematoma, infection, re-intubation, delayed extubation, or respiratory distress. Recently, some surgeons have ceased using drains because they may prolong hospital stay, operative time, or patient discomfort. The objective of this retrospective case-control series is to investigate the effectiveness of postoperative drains following one- and two-level cervical fusions.
A chart review was conducted at a single institution from 2010-2013. Outcome measures included operative time, hospital stay, estimated blood loss and incidence of wound complications (infection, hematoma, edema, and complications with wound healing or evacuation), respiratory complications (delayed extubation, re-intubation, and respiratory treatment), and overall complications (wound complications, respiratory complications, dysphagia, and other complications). Statistical analyses including independent samples t-test, chi-square, analysis of covariance, and linear regression were used to compare patients who received a postoperative drain to those who did not.
The study population included 39 patients who received a postoperative drain and 42 patients who did not. There were no differences in demographics between the two groups. Patients with drains showed increased operative time (100.1 vs 69.3 min, p < 0.001), hospital stay (38.9 vs. 31.7 hrs, p = 0.021), and blood loss (62.7 vs 29.1 mL, p < 0.001) compared to patients without drains. The frequency of wound complications, respiratory complications, and overall complications did not vary significantly between groups.
Conclusions/Level of Evidence
Cervical drains may not be necessary for patients undergoing one- and two-level cervical fusion. While there were no differences in incidence of complications between groups, patients treated with drains had significantly longer operative time and length of hospital stay.
Clinical relevance
This could contribute to excessive costs for patients treated with drains, despite the lack of compelling evidence of the advantages of this treatment in the literature and in the current study.
PMCID: PMC4325495
Cervical wound drain; cervical spine fusion; Spine surgery; postoperative complications
9.  Extensive Postoperative Epidural Hematoma After Full Anticoagulation: Case Report and Review of the Literature 
A 67-year-old man with degenerative lumbar spinal stenosis and a medical history significant for coronary artery disease underwent routine lumbar surgical decompression. The objective of this study was to report a case of postoperative epidural hematoma associated with the use of emergent anticoagulation, including the dangers associated with spinal decompression and early postoperative anticoagulation.
Case report.
After anticoagulation therapy for postoperative myocardial ischemia, the patient developed paresis with ascending abdominal paraesthesias. Immediate decompression of the surgical wound was carried out at the bedside. Magnetic resonance imaging revealed a massive spinal epidural hematoma extending from the middle of the cervical spine to the sacrum. Emergent cervical, thoracic, and revision lumbar laminectomy without fusion was performed to decompress the spinal canal and evacuate the hematoma.
Motor and sensory function returned to normal by 14 days postoperatively, but bowel and bladder function continued to be impaired. Postoperative radiographs showed that coronal and sagittal spinal alignment did not change significantly after extensive laminectomy.
Full anticoagulation should be avoided in the early postoperative period. In cases requiring early vigorous anticoagulation, patients should be closely monitored for changes in neurologic status. Combined cervical, thoracic, and lumbar laminectomy, without instrumentation or fusion, is an acceptable treatment option.
PMCID: PMC2031966  PMID: 17684896
Spinal stenosis, lumbar; Spinal decompression; Anticoagulation; Epidural hematoma; Laminectomy
10.  The role of closed-suction drainage in preventing epidural fibrosis and its correlation with a new grading system of epidural fibrosis on the basis of MRI 
European Spine Journal  2004;14(4):409-414.
In this study we aimed to evaluate the role of closed-suction drainage on the extent of epidural fibrosis (EF) after lumbar disc surgery and to define a new grading system of epidural fibrosis in these patients, based on magnetic resonance imaging. Seventy-nine patients (34 women, 45 men) with a unilateral, single-level lumbar disc herniation were included in this study. Forty-one patients in whom closed-suction drainage was implanted were compared with 38 patients in whom the drain was not implanted. We have used a new grading system for the extent of epidural fibrosis, on the basis of follow-up magnetic resonance imaging findings. Pain intensity was evaluated by visual analog scale (VAS), and the patients’ function and working ability were measured according to the Prolo functional-economic scale. We conclude that, in patients operated on for unilateral, single-level lumbar disc hernias, implantation of closed-suction drainage into the operation site results in less formation of EF radiologically and yields better clinical outcome.
PMCID: PMC3489202  PMID: 15526220
Epidural fibrosis; Closed-suction drainage; Lumbar disc surgery; Magnetic resonance imaging
11.  Post-operative spinal epidural hematoma causing American Spinal Injury Association B spinal cord injury in patients with suction wound drains 
Subfascial wound suction drains are commonly used after spinal surgery to decrease the incidence of post-operative hematoma. However, there is a paucity of literature regarding their effectiveness.
To report four cases of post-operative spinal epidural hematoma causing massive neurological deficit in patients who had subfascial suction wound drains.
During an 8-year period, a retrospective review of 1750 consecutive adult spinal surgery cases was performed to determine the incidence, commonalities, and outcomes of catastrophic neurological deficit caused by post-operative spinal epidural hematoma.
Epidural hematoma causing major neurological deficit (American Spinal Injury Association B) was identified in 4 out of 1750 patients (0.23%). All four patients in this series had subfascial wound suction drains placed prophylactically at the conclusion of their initial procedure.
Three patients developed massive neurological deficits with the drain in place; one patient had the drain removed at 24 hours and subsequently developed neurological symptoms during the following post-operative day. Significant risk factors for the development of hematoma were identified in two of the four patients. Average time to return to the operating room for hematoma evacuation was 6 hours (range 3–12 hours). Neurological status significantly improved in all four patients after hematoma evacuation.
Post-operative epidural hematoma causing catastrophic neurological deficit is a rare complication after spinal surgery. The presence of suction wound drains does not appear to prevent the occurrence of this devastating complication.
PMCID: PMC3654447  PMID: 23809591
Epidural hematoma; Suction drainage; Spinal cord injuries; Laminectomy; Spinal decompression
12.  Is closed-suction drainage necessary after intradural primary spinal cord tumor surgery? 
European Spine Journal  2012;22(3):577-583.
The efficacy of closed-suction drainage in primary intradural spinal cord tumor surgery has not been addressed. We investigated whether closed-suction drainage is essential after primary intradural spinal cord tumor surgery.
From January 2003 to October 2011, 169 consecutive patients with primary intradural spinal cord tumors operated by a single surgeon were selected. Closed-suction drainage was inserted in patients before August 2007, but was not used after August 2007. After removal of tumor and meticulous hemostasis, the opened dura was closed and made watertight using 4-0 silk with interrupt suture and 1.0 cm3 of surgical glue was applied in common. Closed-suction drainage was inserted below the muscular fascia in 75 patients (group I, M:F = 39:36; 46.20 ± 15.63 years) and was not inserted in 94 patients (group II, M:F = 46:48; 51.05 ± 14.89 years).
Neurological deficit precluding ambulation did not occur in all patients. Between group I and II, there were no significant differences in body mass index (22.75 ± 3.16 vs. 23.51 ± 3.22 kg/m2; p = 0.13), laminectomy level (2.45 ± 1.46 vs. 2.33 ± 1.91; p = 0.65), operation time (260.65 ± 109.08 vs. 231.52 ± 90.08 min; p = 0.06), estimated intraoperative blood loss (456.93 ± 406.62 vs. 383.94 ± 257.25 cm3; p = 0.18), and hospital stay period (9.25 ± 5.01 vs. 9.35 ± 5.75 days; p = 0.91). Two patients in group I underwent revision surgery due to wound problems, while revision surgery was not performed in group II (p = 0.20).
Closed-suction drainage may not be essential after primary intradural spinal cord tumor surgery.
PMCID: PMC3585627  PMID: 23001449
Drainage; Spinal cord neoplasms; Complications; Hematoma; Wound infection; Spine
13.  Closed-Suction Drainage and Cerebrospinal Fluid Leakage Following Microvascular Decompression : A Retrospective Comparison Study 
We performed this study to investigate whether the use of closed-suction drainage following microvascular decompression (MVD) causes cerebrospinal fluid (CSF) leakage.
Between 2004 and 2011, a total of 157 patients with neurovascular compression were treated with MVD. MVD was performed for hemifacial spasm in 150 (95.5%) cases and for trigeminal neuralgia in 7 (4.5%) cases. The mean age of the patients was 49.8±9.6 years (range, 20-69). Dural substitutes were used in 44 (28.0%) patients. Ninety-two patients (58.6%) were underwent a 4-5 cm craniotomy using drainage (drainage group), and 65 (41.4%) did a small 2-2.5 cm retromastoid craniectomy without closed-suction drainage (no-drainage group).
Eleven (7.0%) patients experienced CSF leakage following MVD based on the criteria of this study; all of these patients were in the drainage group. In the unadjusted analyses, the incidence of CSF leakage was significantly related with the use of closed-suction drainage following MVD (12.0% in the drainage group vs. 0% in the no-drainage group, respectively; p=0.003; Fisher's exact test). Those who received dural substitutes and the elderly (cut-off value=60 years) exhibited a tendency to develop CSF leakage (p=0.075 and p=0.090, respectively; Fisher's exact test). In the multivariate analysis, only the use of closed-suction drainage was significantly and independently associated with the development of CSF leakage following MVD (odds ratio=9.900; 95% confidence interval, 1.418 to infinity; p=0.017).
The use of closed-suction drainage following MVD appears to be related to the development of CSF leakage.
PMCID: PMC3809436  PMID: 24175025
Microvascular decompression; Cerebrospinal fluid leakage; Closed-suction drainage; Hemifacial spasm; Trigeminal neuralgia
14.  Fibrin sealant does not decrease seroma output or time to drain removal following inguino-femoral lymph node dissection in melanoma patients: A randomized controlled trial (NCT00506311) 
This study assessed the impact of closed suction drains and evaluated whether the intraoperative use of a fibrin sealant decreased time to drain removal and wound complications in melanoma patients undergoing inguino-femoral lymph node dissection.
A pilot study (n = 18) assessed the impact of a closed suction drain following inguino-femoral lymph node dissection. A single-institution, prospective trial was then performed in which patients were randomized to a group that received intraoperative application of a fibrin sealant following inguino-femoral lymph node dissection or to a control group that did not receive sealant.
The majority of the patients enrolled felt the drains caused moderate or severe discomfort and difficulties with activities of daily living. Thirty patients were then randomized; the median time to drain removal in the control group (n = 14) was 30 days (range, 13–74) compared to 29 days (range, 11–45) in the fibrin sealant group (n = 16; P = 0.6). Major and minor complications were similar in the two groups.
Postoperative closed suction drains were associated with major patient inconvenience. Applying a fibrin sealant at the time of inguino-femoral lymph node dissection in melanoma patients did not reduce the time to drain removal or postoperative morbidity. Alternative strategies are needed.
PMCID: PMC2464595  PMID: 18564433
15.  Prospective comparative study of single-layer versus double-layer closure of leg wounds after long saphenous vein harvest in coronary artery bypass graft operations 
Journal of Thoracic Disease  2011;3(3):171-176.
Wound infection is one of the major complication post CABG that leads to prolonged length of stay and cost post surgery. Coronary artery bypass grafting is one of the most commonly performed operations in the world. The long saphenous vein harvested by traditional techniques is still widely used and caries a risk of wound infection.
The purpose of this study is to ascertain if a single-layer closure result in better wound healing and functional outcome as compared with the traditional two-layer closure after harvest of saphenous vein.
Sixty-seven consecutive patients undergoing CABG were prospectively randomized to have their leg wound closed by either a single-layer technique with a suction drain or double layers without suction drain. All wounds were assessed for the presence of serous discharge, inflammation, edema, purulent exudates, infection of the deep tissues, and pain postoperatively and two weeks after discharge.
There were trends towards increased rates of wound related outcomes in patients in double layer group when compared with single layer group. Out of 77 patients in our study, 52 patients underwent single layer closure (males, n = 37; females, n= 15) and 25 patients underwent double layer closure (males, n = 21; females, n = 04). There was significant statistical difference between the treatment groups with single layer group having lower average scores (4.038) compared to double layer group (9.467), P- value 0.001. Patients whose legs were closed with the single layer technique had less post operative edema (23.07% vs 53.30) and pain (44.2 vs 73.33) compared with the double layer group.
Single-layer leg wound closure over a suction drain has shown a better wound outcome compared to traditional double-layer closure. A possible mechanism of better wound healing in the former technique might be through decreased tissue handling and a reduction in leg edema.
PMCID: PMC3256521  PMID: 22263084
single layer closure; double layer closure; saphenous vein
16.  Drainage after total thyroidectomy or lobectomy for benign thyroidal disorders 
Objective: This prospective randomized clinical trial was conducted to evaluate the necessity of drainage after total thyroidectomy or lobectomy for benign thyroidal disorders. Methods: A total of 116 patients who underwent total thyroidectomy or lobectomy for benign thyroidal disorders were randomly allocated to be drained or not. Operative and postoperative outcomes including operating time, postoperative pain assessed by visual analogue scale (VAS), total amount of intramuscular analgesic administration, hospital stay, complications, necessity for re-operation and satisfaction of patients were all assessed. Results: The mean operating time was similar between two groups (the drained and non-drained groups). The mean VAS score was found to be significantly low in the non-drained group patients in postoperative day (POD) 0 and POD 1. The mean amount of intramuscular analgesic requirement was significantly less in the non-drained group. One case of hematoma, two cases of seroma and three cases of transient hypoparathyroidism occurred in the non-drained group, whereas one case of hematoma, two cases of seroma, two cases of wound infections and two cases of transient hypoparathyroidism occurred in the drained group. No patient needed re-operation for any complication. The mean hospital stay was significantly shorter and the satisfaction of patients was superior in the non-drained group. Conclusion: These findings suggest that postoperative complications cannot be prevented by using drains after total thyroidectomy or lobectomy for benign thyroid disorders. Furthermore, the use of drains may increase postoperative pain and the analgesic requirement, and prolong the hospital stay. In the light of these findings, the routine use of drains might not be necessary after thyroid surgery for benign disorders.
PMCID: PMC2276675  PMID: 18381807
Analgesic requirement; Complications; Drainage; Postoperative pain; Total thyroidectomy
17.  Therapy of acute wounds with water-filtered infrared-A (wIRA) 
Water-filtered infrared-A (wIRA) as a special form of heat radiation with a high tissue penetration and with a low thermal load to the skin surface acts both by thermal and thermic as well as by non-thermal and non-thermic effects. wIRA produces a therapeutically usable field of heat in the tissue and increases tissue temperature, tissue oxygen partial pressure, and tissue perfusion. These three factors are decisive for a sufficient tissue supply with energy and oxygen and consequently as well for wound healing and infection defense.
wIRA can considerably alleviate the pain (with remarkably less need for analgesics) and diminish an elevated wound exudation and inflammation and can show positive immunomodulatory effects. wIRA can advance wound healing or improve an impaired wound healing both in acute and in chronic wounds including infected wounds. Even the normal wound healing process can be improved.
A prospective, randomized, controlled, double-blind study with 111 patients after major abdominal surgery at the University Hospital Heidelberg, Germany, showed with 20 minutes irradiation twice a day (starting on the second postoperative day) in the group with wIRA and visible light VIS (wIRA(+VIS), approximately 75% wIRA, 25% VIS) compared to a control group with only VIS a significant and relevant pain reduction combined with a markedly decreased required dose of analgesics: during 230 single irradiations with wIRA(+VIS) the pain decreased without any exception (median of decrease of pain on postoperative days 2-6 was 13.4 on a 100 mm visual analog scale VAS 0-100), while pain remained unchanged in the control group (p<0.001). The required dose of analgesics was 57-70% lower in the subgroups with wIRA(+VIS) compared to the control subgroups with only VIS (median 598 versus 1398 ml ropivacaine, p<0.001, for peridural catheter analgesia; 31 versus 102 mg piritramide, p=0.001, for patient-controlled analgesia; 3.4 versus 10.2 g metamizole, p=0.005, for intravenous and oral analgesia). During irradiation with wIRA(+VIS) the subcutaneous oxygen partial pressure rose markedly by approximately 30% and the subcutaneous temperature by approximately 2.7°C (both in a tissue depth of 2 cm), whereas both remained unchanged in the control group: after irradiation the median of the subcutaneous oxygen partial pressure was 41.6 (with wIRA) versus 30.2 mm Hg in the control group (p<0.001), the median of the subcutaneous temperature was 38.9 versus 36.4°C (p<0.001). The overall evaluation of the effect of irradiation, including wound healing, pain and cosmesis, assessed on a VAS (0-100 with 50 as indifferent point of no effect) by the surgeon (median 79.0 versus 46.8, p<0.001) or the patient (79.0 versus 50.2, p<0.001) was markedly better in the group with wIRA compared to the control group. This was also true for single aspects: Wound healing assessed on a VAS by the surgeon (median 88.6 versus 78.5, p<0.001) or the patient (median 85.8 versus 81.0, p=0.040, trend) and cosmetic result assessed on a VAS by the surgeon (median 84.5 versus 76.5, p<0.001) or the patient (median 86.7 versus 73.6, p=0.001). In addition there was a trend in favor of the wIRA group to a lower rate of total wound infections (3 of 46, approximately 7%, versus 7 of 48, approximately 15%, p=0.208) including late infections after discharge, caused by the different rate of late infections after discharge: 0 of 46 in the wIRA group and 4 of 48 in the control group. And there was a trend towards a shorter postoperative hospital stay: 9 days in the wIRA group versus 11 days in the control group (p=0.037). The principal finding of this study was that postoperative irradiation with wIRA can improve even a normal wound healing process.
A prospective, randomized, controlled, double-blind study with 45 severely burned children at the Children’s Hospital Park Schönfeld, Kassel, Germany, showed with 30 minutes irradiation once a day (starting on the first day, day of burn as day 1) in the group with wIRA and visible light VIS (wIRA(+VIS), approximately 75% wIRA, 25% VIS) compared to a control group with only VIS a markedly faster reduction of wound size. On the fifth day (after 4 days with irradiation) decision was taken, whether surgical debridement of necrotic tissue was necessary because of deeper (second degree, type b) burns (11 of 21 in the group with wIRA, 14 of 24 in the control group) or non-surgical treatment was possible (second degree, type a, burns). The patients treated conservatively were kept within the study and irradiated till complete reepithelialization. The patients in the group with wIRA showed a markedly faster reduction of wound area: a median reduction of wound size of 50% was reached already after 7 days compared to 9 days in the control group, a median reduction of wound size of 90% was already achieved after 9 days compared to 13 days in the control group. In addition the group with wIRA showed superior results till 3 months after the burn in terms of the overall surgical assessment of the wound, cosmesis, and assessment of effects of irradiation compared to the control group.
In a prospective, randomized, controlled study with 12 volunteers at the University Medical Center Charité, Berlin, Germany, within each volunteer 4 experimental superficial wounds (5 mm diameter) as an acute wound model were generated by suction cup technique, removing the roof of the blister with a scalpel and a sterile forceps (day 1). 4 different treatments were used and investigated during 10 days: no therapy, only wIRA(+VIS) (approximately 75% wIRA, 25% VIS; 30 minutes irradiation once a day), only dexpanthenol (= D-panthenol) cream once a day, wIRA(+VIS) and dexpanthenol cream once a day. Healing of the small experimental wounds was from a clinical point of view excellent with all 4 treatments. Therefore there were only small differences between the treatments with slight advantages of the combination wIRA(+VIS) and dexpanthenol cream and of dexpanthenol cream alone concerning relative change of wound size and assessment of feeling of the wound area. However laser scanning microscopy with a scoring system revealed differences between the 4 treatments concerning the formation of the stratum corneum (from first layer of corneocytes to full formation) especially on the days 5-7: fastest formation of the stratum corneum was seen in wounds treated with wIRA(+VIS) and dexpanthenol cream, second was wIRA(+VIS) alone, third dexpanthenol cream alone and last were untreated wounds. Bacterial counts of the wounds (taken every 2 days) showed, that wIRA(+VIS) and the combination of wIRA(+VIS) with dexpanthenol cream were able to inhibit the colonisation with physiological skin flora up to day 5 when compared with the two other groups (untreated group and group with dexpanthenol cream alone). At any investigated time, the amount of colonisation under therapy with wIRA(+VIS) alone was lower (interpreted as more suppressed) compared with the group with wIRA(+VIS) and dexpanthenol cream.
During rehabilitation after hip and knee endoprosthetic operations the resorption of wound seromas and wound hematomas was both clinically and sonographically faster and pain was reduced by irradiation with wIRA(+VIS).
wIRA can be used successfully for persistent postoperative pain e.g. after thoracotomy.
As perspectives for wIRA it seems clinically prudent to use wIRA both pre- and postoperatively, e.g. in abdominal and thoracic operations. wIRA can be used preoperatively (e.g. during 1-2 weeks) to precondition donor and recipient sites of skin flaps, transplants or partial-thickness skin grafts, and postoperatively to improve wound healing and to decrease pain, inflammation and infections at all mentioned sites. wIRA can be used to support routine pre- or intraoperative antibiotic administration or it might even be discussed to replace this under certain conditions by wIRA.
PMCID: PMC2831241  PMID: 20204084
water-filtered infrared-A (wIRA); wound healing; acute wounds; prospective, randomized, controlled, double-blind studies; reduction of pain; problem wounds; wound infections; infection defense; wound exudation; inflammation; thermal and non-thermal effects; thermic and non-thermic effects; energy supply; oxygen supply; tissue oxygen partial pressure; tissue temperature; tissue blood flow; visual analog scales (VAS); quality of life
18.  Early postoperative MRI in detecting hematoma and dural compression after lumbar spinal decompression: prospective study of asymptomatic patients in comparison to patients requiring surgical revision 
European Spine Journal  2010;19(12):2216-2222.
Early postoperative MRI after spinal surgery is difficult to interpret because of confounding postoperative mass effects and frequent occurrence of epidural hematomas. Purpose of this prospective study is to evaluate prevalence, extent and significance of hematoma in the first postoperative week in asymptomatic patients after decompression for lumbar stenosis and to determine the degree of clinically significant dura compression by comparing with the patients with postoperative symptoms. MRI was performed in 30 asymptomatic patients (47 levels) in the first week after lumbar spine decompression for degenerative stenosis. Eleven patients requiring surgical revision (16 levels) for symptomatic early postoperative hematoma were used for comparison. In both groups the cross-sectional area of the maximum dural compression (bony stenosis and dural sac expansion) was measured preoperatively and postoperatively by an experienced radiologist. Epidural hematoma was seen in 42.5% in asymptomatic patients (20/47 levels). The median area of postoperative hematoma at the operated level was 176 mm2 in asymptomatic patients and 365 mm2 in symptomatic patients. The median cross-sectional area of the dural sac at the operated level was 128.5 and 0 mm2 in asymptomatic and symptomatic patients, respectively, at the site of maximal compression. In the symptomatic group 75% of the patients had a maximal postoperative dural sac area of 58.5 mm2 or less, whereas in the asymptomatic group 75% of patients with epidural hematoma had an area of 75 mm2 or more. The size of hematoma and the degree of dural sac compression were significantly larger in patients with symptoms needing surgical revision. Dural sac area of less than 75 mm2 in early postoperative MRI was found to be the threshold for clinical significance.
PMCID: PMC2997206  PMID: 20556438
Epidural hematoma; Early postoperative MRI; Spinal stenosis; Neural compression
19.  Closed suction drains, reinfusion drains or no drains in primary total knee replacement? 
Controversy still surrounds the use of drains after total knee replacement (TKR). We compared closed suction drains, reinfusion drains and no drains by studying haemoglobin (Hb) levels, blood transfusion requirements and functional knee outcome scores in a single surgeon series.
A total of 102 consecutive primary TKRs were performed by the senior author between September 2006 and July 2008. All were cemented fixed bearing devices with patellar resurfacing. Of the 102 patients, 30 had closed suction drainage, 33 had an unwashed reinfusion drainage system and 39 had no drains. Data regarding pre and post-operative Hb and units transfused were gathered retrospectively. Pre and post-operative American Knee Society scores (AKSS) and Oxford knee scores (OKS) were recorded prospectively.
The pre-operative Hb levels were comparable among the groups. There was no statistically significant difference in Hb level reduction or autologous transfusion rates among the groups. Pre-operative AKSS and OKS were statistically comparable in each group. There was no statistical difference between the improvement in AKSS knee and function scores in all three groups. There was a slightly smaller improvement in the OKS of the ‘no drain’ group. There were no complications of drain usage and no deep infections. No patient required manipulation under anaesthesia and range of movement outcomes were the same for each group.
Our study does not support the use of either closed suction drains or reinfusion drains in primary elective TKR.
PMCID: PMC3954378  PMID: 22943232
Total knee arthroplasty; Autologous transfusion; Reinfusion drains; Haemoglobin; Blood transfusion
20.  Negative Pressure Wound Therapy 
Executive Summary
This review was conducted to assess the effectiveness of negative pressure wound therapy.
Clinical Need: Target Population and Condition
Many wounds are difficult to heal, despite medical and nursing care. They may result from complications of an underlying disease, like diabetes; or from surgery, constant pressure, trauma, or burns. Chronic wounds are more often found in elderly people and in those with immunologic or chronic diseases. Chronic wounds may lead to impaired quality of life and functioning, to amputation, or even to death.
The prevalence of chronic ulcers is difficult to ascertain. It varies by condition and complications due to the condition that caused the ulcer. There are, however, some data on condition-specific prevalence rates; for example, of patients with diabetes, 15% are thought to have foot ulcers at some time during their lives. The approximate community care cost of treating leg ulcers in Canada, without reference to cause, has been estimated at upward of $100 million per year.
Surgically created wounds can also become chronic, especially if they become infected. For example, the reported incidence of sternal wound infections after median sternotomy is 1% to 5%. Abdominal surgery also creates large open wounds. Because it is sometimes necessary to leave these wounds open and allow them to heal on their own (secondary intention), some may become infected and be difficult to heal.
Yet, little is known about the wound healing process, and this makes treating wounds challenging. Many types of interventions are used to treat wounds.
Current best practice for the treatment of ulcers and other chronic wounds includes debridement (the removal of dead or contaminated tissue), which can be surgical, mechanical, or chemical; bacterial balance; and moisture balance. Treating the cause, ensuring good nutrition, and preventing primary infection also help wounds to heal. Saline or wet-to-moist dressings are reported as traditional or conventional therapy in the literature, although they typically are not the first line of treatment in Ontario. Modern moist interactive dressings are foams, calcium alginates, hydrogels, hydrocolloids, and films. Topical antibacterial agents—antiseptics, topical antibiotics, and newer antimicrobial dressings—are used to treat infection.
The Technology Being Reviewed
Negative pressure wound therapy is not a new concept in wound therapy. It is also called subatmospheric pressure therapy, vacuum sealing, vacuum pack therapy, and sealing aspirative therapy.
The aim of the procedure is to use negative pressure to create suction, which drains the wound of exudate (i.e., fluid, cells, and cellular waste that has escaped from blood vessels and seeped into tissue) and influences the shape and growth of the surface tissues in a way that helps healing. During the procedure, a piece of foam is placed over the wound, and a drain tube is placed over the foam. A large piece of transparent tape is placed over the whole area, including the healthy tissue, to secure the foam and drain the wound. The tube is connected to a vacuum source, and fluid is drawn from the wound through the foam into a disposable canister. Thus, the entire wound area is subjected to negative pressure. The device can be programmed to provide varying degrees of pressure either continuously or intermittently. It has an alarm to alert the provider or patient if the pressure seal breaks or the canister is full.
Negative pressure wound therapy may be used for patients with chronic and acute wounds; subacute wounds (dehisced incisions); chronic, diabetic wounds or pressure ulcers; meshed grafts (before and after); or flaps. It should not be used for patients with fistulae to organs/body cavities, necrotic tissue that has not been debrided, untreated osteomyelitis, wound malignancy, wounds that require hemostasis, or for patients who are taking anticoagulants.
Review Strategy
The inclusion criteria were as follows:
Randomized controlled trial (RCT) with a sample size of 20 or more
Human study
Published in English
Summary of Findings
Seven international health technology assessments on NPWT were identified. Included in this list of health technology assessments is the original health technology review on NPWT by the Medical Advisory Secretariat from 2004. The Medical Advisory Secretariat found that the health technology assessments consistently reported that NPWT may be useful for healing various types of wounds, but that its effectiveness could not be empirically quantified because the studies were poorly done, the patient populations and outcome measures could not be compared, and the sample sizes were small.
Six RCTs were identified that compared NPWT to standard care. Five of the 6 studies were of low or very low quality according to Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. The low and very low quality RCTs were flawed owing to small sample sizes, inconsistent reporting of results, and patients lost to follow-up. The highest quality study, which forms the basis of this health technology policy assessment, found that:
There was not a statistically significant difference (≥ 20%) between NPWT and standard care in the rate of complete wound closure in patients who had complete wound closure but did not undergo surgical wound closure (P = .15).
The authors of this study did not report the length of time to complete wound closure between NPWT and standard care in patients who had complete wound closure but who did not undergo surgical wound closure
There was no statistically significant difference (≥ 20%) in the rate of secondary amputations between the patients that received NPWT and those that had standard care (P = .06)
There may be an increased risk of wound infection in patients that receive NPWT compared with those that receive standard care.
Based on the evidence to date, the clinical effectiveness of NPWT to heal wounds is unclear. Furthermore, saline dressings are not standard practice in Ontario, thereby rendering the literature base irrelevant in an Ontario context. Nonetheless, despite the lack of methodologically sound studies, NPWT has diffused across Ontario.
Discussions with Ontario clinical experts have highlighted some deficiencies in the current approach to wound management, especially in the community. Because NPWT is readily available, easy to administer, and may save costs, compared with multiple daily conventional dressing changes, it may be used inappropriately. The discussion group highlighted the need to put in place a coordinated, multidisciplinary strategy for wound care in Ontario to ensure the best, continuous care of patients.
PMCID: PMC3379164  PMID: 23074484
21.  Postoperative autologous blood transfusion drain or no drain in primary total hip arthroplasty? A randomised controlled trial 
International Orthopaedics  2012;36(10):2033-2039.
Postoperative maintenance of high haemoglobin (Hb) levels and avoidance of homologous blood transfusions is important in total hip arthroplasty (THA). The introduction of a postoperative drainage autologous blood transfusion (ABT) system or no drainage following THA has resulted in reduction of homologous blood transfusion requirements compared with closed-suction drains. The purpose of this study was to examine which regimen is superior following THA.
A randomised controlled blinded prospective single-centre study was conducted in which 100 THA patients were randomly allocated to ABT or no drainage. The primary endpoint was the Hb level on the first postoperative day.
The postoperative collected drained blood loss was 274 (±154) ml in the ABT group, of which 129 (±119) ml was retransfused (0–400). There was no statistical difference in Hb levels on the first postoperative day (ABT vs no drainage: Hb 11.0 vs 10.9 g/dl), on consecutive days (day 3: Hb 10.7 vs 10.2, p = 0.08) or in total blood loss (1,506 vs 1,633 ml), homologous transfusions, pain scores, Harris Hip Score, SF-36 scores, length of hospital stay or adverse events.
The use of a postoperative autologous blood retransfusion drain did not result in significantly higher postoperative Hb levels or in less total blood loss or fewer homologous blood transfusions compared with no drain.
PMCID: PMC3460103  PMID: 22790978
22.  Abdominal drainage following cholecystectomy: high, low, or no suction? 
A prospective trial to assess the effect of suction in an abdominal drain following cholecystectomy was carried out. Three types of closed drainage system were compared: a simple tube drain, a low negative pressure drain, and a high negative pressure drain: 120 consecutive patients undergoing cholecystectomy were randomly allocated to one of the three drainage groups. There was no significant difference in postoperative pyrexia, wound infection, chest infection, or hospital stay. This study failed to demonstrate any clinically useful difference between high negative pressure, low negative pressure, and static drainage system were compared: a simple tube drain, a low negative used, suction is not necessary and a simple tube drain (greater than 6 mm internal diameter) is the most effective form of drainage.
PMCID: PMC2494372  PMID: 6614773
23.  Utilization of Preoperative Cerebrospinal Fluid Drain in Skull Base Surgery 
Skull Base  2007;17(2):133-139.
Objective: Retrospectively assess the efficacy of lumbar cerebrospinal fluid (CSF) drainage placed preoperatively in skull base operations in decreasing the incidence of postoperative CSF fistula. Methods: A retrospective review of 150 patients undergoing a posterior fossa craniotomy from 1989 to 2000 was conducted. Patients were divided into those receiving preoperative lumbar drains and those that did not. The rates of postoperative CSF leakage were compared between the two groups. Patient data were analyzed to determine if there were other comorbidities affecting the postoperative incidence of CSF leakage such as smoking, diabetes, or hypertension. Results: Between 1989 and 1994, 25/72 (35%) patients with no preoperative lumbar drain had a postoperative CSF leak. From 1995 to 2000, 9/78 (12%) patients with a preoperative lumbar drain had a CSF leak. This was a 23% decreased incidence of postoperative CSF leakage and a significant decrease in the probability (p < 0.001) of CSF leakage in patients treated with a preoperative lumbar drain. The comorbidities of diabetes, smoking, or hypertension did not increase the probability of a CSF leak (p = 0.43). Conclusions: A preoperatively placed lumbar drain can significantly lower the rate of postoperative CSF leakage after skull base surgery. The drain is a well-tolerated adjunct to dural closure and helps increase surgical exposure of the posterior fossa. The comorbidities of diabetes, smoking, or hypertension do not contribute to an increased rate of CSF leakage.
PMCID: PMC1876157  PMID: 17768443
Cerebrospinal fluid fistula; lumbar drain; retrosigmoid; translabyrinthine
24.  Prolonged suction drainage prevents serous wound discharge after cardiac surgery. 
A series of 180 patients was randomised to two groups after median sternotomy performed for cardiac surgery in order to evaluate the effect of suction drainage on serous wound discharge. In group A all wounds were drained using two conventional mediastinal drains, while in group B one suction drain and one conventional mediastinal drain were employed. Five patients developed serous wound discharge in group B compared with 14 in group A (chi 2, P < 0.02). There were no significant differences between the rates of major wound infection (group A, n = 1; group B, n = 1) or the incidence of postoperative pericardial effusion assessed by echocardiography (group A, n = 10; group B, n = 5).
PMCID: PMC2502194  PMID: 8117016
25.  Does LigaSure™ reduce fluid drainage in axillary dissection? A randomized prospective clinical trial 
Axillary lymph node dissection (ALND) is an integral part of breast cancer treatment. It is required in about 40–50% of patients. The placement of a drain in the axilla after an operation is current surgical practice. Short surgical stay programmes increase operating efficiency and reduce medical care costs, without compromising quality of care. LigaSure™ is a new haemostatic device that uses bipolar energy to seal vessels. The aim of this study is to determine whether axillary dissection with LigaSure™ reduces the time of wound drainage, the duration of surgical intervention and the volume of drainage after treatment.
Patients and methods:
This study is a prospective randomized controlled trial. A total of 100 women with breast cancer who needed axillary dissection were randomized into the LigaSure™ or conventional axillary dissection group. Levels I to III lymph node dissection was performed. A closed suction drain was always placed in the axilla and removed after 6–8 days or when fluid amount was <60 cc in the previous 24 hours.
There were no significant differences between the two groups when considering the duration of surgical procedure: average duration was 70.7 ± 24.66 minutes for LigaSure™ patients, while in the conventional dissection group the mean was 70.6 ± 22.47 minutes (p=0.98). Total amount of drained fluid was 624.49 cc in the LigaSure™ axillary dissection group and 792.96 in the conventional ALND group; this difference did not achieve statistical significance (p=0.09); the duration of draining was also similar, with no statistical difference (p=0.15).
The present study did not show clear advantages in LigaSure™ use for ALND, although it represents a good haemostatic device, especially in abdominal surgery.
PMCID: PMC3223974  PMID: 22275958
Breast carcinoma; breast cancer surgery; axillary dissection; seroma; drain; haemostasis; LigaSure

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