Development of a New Incontinence Containment Product and an Investigation of Its Effect on Perineal Dermatitis in Patients With Fecal Incontinence: A Pilot Study in Women

Abstract

The purpose of this 2-part study was to 1) develop a new incontinence containment product for fecal incontinence and 2) examine the effect of this new product on the occurrence of incontinence-associated dermatitis (IAD). In part 1, a new incontinence containment product was designed, developed, and trialed among 10 healthy female volunteers. The product was comprised of a double layer of polypropylene nonwoven fabric and 100% cotton interlock fabric with a 3-ply 100% cotton interlock fabric added into the perianal section. Participants wore the product for 8 hours and were asked to defecate into the product and evaluate its comfort, ability to contain liquids and protect privacy, any personal allergic reaction, and air permeability. In part 2, after any product modifications, 12 bedridden women treated in the neurology unit of a hospital in western Turkey who had an indwelling urinary catheter and fecal incontinence and who did not have diabetes mellitus, a darkly pigmented area in the perianal area, pressure injury, or erythema were randomized to 2 groups (study product and control, a premium adult diaper) and monitored for 8 days for the development and severity of perineal dermatitis (scored from 0 [no erythema] to 4 [broken, abraded skin]) using a skin assessment tool. Any type of erythema was considered IAD. Skin care (cleansing with a washcloth and water) was provided daily and after each defecation to all study participants. Data were collected via paper-and-pencil completion of the perineal skin integrity assessment and patient observation forms and entered into and analyzed by a computerized statistical program. Fisher's exact test and the chi-squared test were used to analyze the difference in IAD incidence and severity between the 2 groups, and the Mann Whitney U test was used to detect differences in the number and consistency of defecations. No statistically significant differences were noted among the characteristics of the 12 participants (6 in each group) except for age; patients in the study product group were significantly older (70.66 ± 10.36 vs 52.20 ± 16.78 years; P <.05. Four (4) patients in the study group exhibited 13 areas of perineal dermatitis (degree 1 = 6 areas; degree 2 = 6 areas; degree 3 = 1 area; and degree 4 = 0); 1 patient in the control group had 4 areas with degree 1. This prototype product is not sufficient to be used in clinical practice in patients with fecal incontinence, but further study in a larger population is warranted..