In this randomized trial, Saul Rajak et al. compare silk sutures (removed at 7–10 days) or absorbable sutures (left in place) during surgery for the management of trachomatous trichiasis.
Background
Trachoma causes blindness through an anatomical abnormality called trichiasis (lashes touching the eye). Trichiasis can recur after corrective surgery. We tested the hypothesis that using absorbable sutures instead of silk sutures might reduce the risk of recurrent disease among patients with major trichiasis in a randomised trial.
Methods and Findings
1,300 individuals with major trichiasis from rural villages in the Amhara Region of Ethiopia were recruited and assigned (1∶1) by computer-generated randomisation sequence to receive trichiasis surgery using either an absorbable suture (polyglactin-910) or silk sutures (removed at 7–10 days) in an otherwise identical surgical technique. Participants were examined every 6 months for 2 years by clinicians masked to allocation. The primary outcome measure was recurrent trichiasis (≥one lash touching the eye) at 1 year. There was no difference in prevalence of recurrent trichiasis at 1 year (114 [18.2%] in the absorbable suture group versus 120 [19.7%] in the silk suture group; odds ratio = 0.90, 95% CI 0.68–1.20). The two groups also did not differ in terms of corneal opacification, visual acuity, conjunctival inflammation, and surgical complications.
Conclusions
There was no evidence that use of absorbable polyglactin-910 sutures was associated with a lower prevalence of trichiasis recurrence at 1 year postsurgery than silk sutures. However, from a programmatic perspective, polyglactin-910 offers the major advantage that patients do not have to be seen soon after surgery for suture removal. The postoperative review after surgery using absorbable polyglactin-910 sutures can be delayed for 3–6 months, which might allow us to better determine whether a patient needs additional surgery.
Trial registration
ClinicalTrials.gov NCT00522860
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Globally, around 40 million people—mostly people living in rural areas in developing countries where there are water shortages, poor personal hygiene, and crowded living conditions—have active trachoma, an infectious eye disease that is caused by Chlamydia trachomatis. This bacterium is spread through contact with infected eye secretions or with contaminated towels or clothes, and by flies. Recurrent infections with C. trachomatis during early childhood cause inflammation of the tissue lining the eye lid (chronic conjunctival inflammation), which can lead to conjunctival scarring. If this scarring is severe, the eyelids turn inwards (entropion) and the lashes rub across the eye's surface (the cornea). This condition—trachomatous trichiasis—is extremely painful and, if not treated with surgery, can lead to irreversible corneal opacities and visual impairment by middle age. It is estimated that 8 million people have trichiasis and that an additional 8 million people are blind or visually impaired as a result of the condition.
Why Was This Study Done?
Surgery for trichiasis, antibiotics for infection, and facial cleanliness and environmental improvements to reduce transmission together constitute the SAFE strategy for the control of blinding trachoma. Unfortunately, trichiasis recurs in nearly two-thirds of patients within 3 years of surgery, often within the first year. How the surgery is performed, its quality, and the severity of entropion and conjunctival scarring at the time of surgery all contribute to trichiasis recurrence. In this randomized trial (a study in which randomly chosen groups of patients receive different treatments for a disease and are followed to compare the outcomes of these interventions), the researchers investigate whether using absorbable sutures instead of silk sutures reduces the risk of recurrent disease among patients with major trichiasis (more than five lashes touching the cornea). Sutures are used to sew up surgical incisions. Silk sutures, which are used routinely during trichiasis surgery, have to be removed 7–10 days after surgery when the incision may not have stably healed. Absorbable sutures might provide more stable fixation of the eye tissue while healing is taking place and might, therefore, reduce the recurrence of trichiasis after surgery.
What Did the Researchers Do and Find?
The researchers randomly assigned 1,300 people living in Ethiopia (the country with the highest rates of trachoma and trichiasis) to receive trichiasis surgery using silk sutures (removed at 7–10 days) or absorbable sutures (left in place); the other details of the surgery were identical for all the patients. The trial's primary outcome was recurrent trichiasis (one or more lash touching the eye) at 1 year. Secondary outcomes included the rate of recurrence, visual acuity, corneal opacity, and conjunctival inflammation at 2 years, and surgical complications. At 1 year, 18.2% of the patients in the absorbable suture group and 19.7% in the silk suture group had developed recurrent trichiasis. That is, the prevalence of recurrence in the two groups was similar. There was also no difference in the rate of trichiasis recurrence between the groups 2 years after surgery. Moreover, the two groups did not differ in terms of corneal opacity and visual acuity, conjunctival inflammation, or surgical complications.
What Do These Findings Mean?
These findings provide no evidence to suggest that the use of absorbable sutures during trichiasis surgery is clinically better than the use of silk sutures. However, the researchers note that the use of absorbable sutures would eliminate the need for patients to return to the clinic soon after their operation to have their sutures removed. In remote rural settings, it can be difficult for patients, who are often elderly and poor, to attend clinics. Thus, it might be better for trachoma services to concentrate on encouraging patients to return 3–6 months after surgery when the need for additional surgery can be determined rather than trying to encourage them to come back after 7–10 days for suture removal. The use of absorbable sutures would also avoid any complications arising from patients failing to come back to have their stitches removed. The researchers suggest, therefore, that trachoma control programs should now consider the potential logistical advantages of using absorbable sutures rather than silk sutures during trichiasis surgery despite the lack of any apparent clinical difference between the two suture types.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001137.
An accompanying PLoS Medicine Research Article by Saul Rajak et al. describes another randomized trial undertaken by these researchers that compares surgery and epilation (eyelash removal) for the treatment of trichiasis in Ethiopia
The World Health Organization has information on trachoma (in several languages), including details of the Alliance for Global Elimination of Trachoma by the year 2020 (GET 2020) and a personal story about blinding trachoma
The UK National Health Service Choices website also provide information on trachoma
Orbis, an international nonprofit organization devoted to blindness prevention and treatment in developing countries, provides information about trachoma
The International Trachoma Initiative provides detailed information about trachoma and a personal story about trichiasis surgery in Ethiopia
The Global Atlas of Trachoma is an open-access resource on the geographical distribution of trachoma
Light for the World is a nonprofit organization dedicated to ensuring the rights of persons with disabilities in developing countries, including people in Ethiopia with trachoma