The present cluster randomized controlled trial examined the hypothesis that the skin condition of older women improves faster with the use of the test absorbent pad than with conventional products. We observed that significantly faster recovery could be achieved using the test absorbent pad.
IAD is the result of damage to the skin when exposed to stool or urine. Prolonged exposure to higher than normal levels of water results in maceration, barrier breakdown, disruption of intercellular lamellar lipid bilayers, degeneration of corneodesmosomes, and formation of amorphous regions within the intercellular lipid [3
]. Moreover, when urine is excreted into the absorbent pad, urea in the urine is broken down to ammonia, which tends to tip the scale towards the alkaline side, thereby irritating the skin. Chemical and physical stimuli due to frequent cleansing enhance skin permeability and decrease skin barrier function. These factors weaken the skin, which then triggers IAD [6
]. Randomized, controlled trials (RCT) investigating effective management of IAD through skin care programs or the use of incontinence pads have been previously conducted. As for skin care programs, there are a number of studies particularly on skin cleansers, skin protectors, and moisturizers [7
]. However, even after these treatments, patients develop IAD. For this reason, we came to recognize the importance of improving the incontinence absorbent pad that is in direct contact with the skin. In terms of incontinence absorption pads, studies have reported improved skin condition with the use of pads containing absorbent polymers [16
]. Even with the use of absorbent polymers, however, there remained a significant association between the pH level of the incontinence pad surface and that of the skin, which is a risk factor for developing IAD [16
]. To prevent alkalinization of the skin, Beguin et al.
] developed an absorbent pad that consisted of an absorbent layer with a specially formulated pH-controlling fiber and a highly breathable material in the side panel that can maintain a weakly acidic skin pH. In the clinical evaluation of that pad, a case series of 12 elderly patients with IAD was studied, and full recovery was reported in 8 patients on day 21 of use. However, since the study did not have a control group, and its results were inclusive of natural healing process, the true efficacy of the pad in curing IAD is unknown.
In this study we were able to demonstrate that significantly faster recovery could be achieved using the test absorbent pad. Our previous studies demonstrated that effective frontal absorption of the test absorbent pad and its mechanism to prevent urine from seeping back to the surface significantly reduced the pH level of the pad [12
]. This condition is believed to have facilitated full recovery from IAD. However, although a significant difference was observed in the healing rate, the proportion of patients with no change or aggravation in skin condition was similar for both the test absorbent pad group (43.3%) and the control group (50.0%). In addition, there were no significant differences in the moisture content of the stratum corneum of the skin on the coccyx and the skin pH level. The reason for these may be due to the study design that the test absorbent pad group used the control group’s absorbent pad at night, which may have had an influencing effect. The reason for this switch pad was that the allowance volume of the test pad.
A limitation is that this study targeted bedridden older women and therefore its findings do not apply to elderly people leading sedentary or ambulatory lifestyles. Our sample size was not based on the power analysis.