Design. A randomized controlled clinical trial was conducted between February 2013 and July 2015 at a university in western Turkey.
Part 1: Prototype development and testing.
Prototype development. The data of the first part of the study were collected between February 2 and February 28, 2015. After the first author took a 1-semester course in medical wear at the Textile Engineering Department of the Institute of Science and Technology, Izmir, Turkey, a faculty member from the Department of Textile Engineering of the university’s Faculty of Engineering was consulted to help develop a new incontinence containment product. Diaper manufacturers were asked via telephone and email to provide samples, which were tested in the experimental laboratories of the Textile and Apparel Research and Application Center of the Institute of Science and Technology for air permeability, surface friction, and thickness. The materials that gave the best results after the analysis were used as the raw material for the care prototype.
The incontinence containment product prototype was designed and manufactured using a double layer of polypropylene nonwoven fabric and a 100% cotton interlock fabric. Additionally, a 3-ply 100% cotton interlock fabric was used in the perianal section of the new product. Three different sizes (40–80 kg) were produced. The goal was to construct an incontinence containment product that accommodated the patient’s size and that increased air permeability by using a nonwoven material. The authors also wanted to avoid the mixing of urine and feces in order to prevent a rise in the pH of the diaper area. At this stage, experiments of wearing this prototype product were conducted with healthy volunteer study participants.
Participant sample (healthy individuals). When the prototype was first developed, experiments were conducted among 10 healthy volunteer study participants who were at least 18 years of age and who agreed to wear the product for 8 hours. Participants were recruited by physicians working in the faculty of occupational health and safety unit of the university where health status is periodically checked; inclusion criteria stipulated participants be healthy and free of dermatological disease.
Participants were asked to wear this product and conduct clothing experiments. They were requested to defecate while wearing the product then asked about any discomfort during this period and to answer questions about the product. A questionnaire was developed based on the literature.2,4,18,28 Expert opinion was obtained from research team members (a textile academician, a dermatologist, and 2 nurse academicians). The questionnaire consisted of 9 multiple choice and open-ended questions. Participants also were asked to evaluate the product in terms of clothing comfort features (fabric type, product model, easy wearing and removal, type of fastening, whether it held liquids, protection of privacy, whether it elicited an allergic effect, and whether it was air-tight), and they completed a questionnaire relating to the features of the new diapers. Face-to-face interviews were conducted by first author. Participant skin was checked by the fourth author for any reaction in terms of allergic contact dermatitis or irritant contact dermatitis. The incontinence containment product prototype could be modified at this point according to these results. Women who did not complete the 8-hour period of the clothing experiment were excluded from the study. In the case of any reaction, the participant was examined by the dermatologist.
Part 2: The effect of the incontinence containment product on perineal dermatitis.
Participant sample. The second part of the study was conducted between April 2 and July 3, 2015. Once the prototype was developed and the clothing experiments had been conducted in healthy women, a sample consisting of 12 female bedridden patients from the neurology unit of a hospital in western Turkey who had fecal incontinence was enrolled. Patients >18 years of age with intact perineal and perianal skin and an indwelling urethral catheter who agreed to participate were eligible for the study. Patients who had diabetes mellitus (diabetic neuropathy causes weakness in tissue tolerance and the development of perineal dermatitis26), a darkly pigmented perineal area, pressure injuries or erythema, or who did not agree to participate in the study were excluded.
Procedure. Patients were randomized into experimental product and control diaper groups according to age by flipping a coin. In the control group, an adult diaper (Pads, Linea Tena, SCA, Hygiene, Göteborg, Sweden) a premium quality adult diaper, was chosen for use as a result of analysis conducted at the Textile Faculty laboratories and because it was similar to the products normally used in the population. This diaper consists of 3 layers: the outer layer is made of polyethylene film, the middle layer is made of superabsorbent polymer, and the inner layer is made of nonwoven polypropylene fabric. Patients were provided either the new incontinence containment product prototype or the control diaper and monitored for the development of perineal dermatitis for 7 days. A Patient Identification Form, a Perineal Skin Integrity Assessment Form, and a Patient Observation Form were used for data collection. Perineal care was given to patients in both groups twice a day and after each defecation. The diaper or the new incontinence containment product was changed after each perineal care session. The skin care included cleaning perineal areas with water using a washcloth. The diaper and new incontinence containment devices of patients in both groups were changed every day and after each defecation.
The Patient Identification Form consisted of 5 questions including age, medical diagnosis, degree of activity, presence of chronic disease, body mass index, and method of nutrition. These data were obtained from the medical records of the hospital and were recorded by the first author at the beginning of the study.
The Perineal Skin Integrity Assessment Form was used to evaluate and record the skin integrity. The visual scale based on the International Contact Dermatitis Score and that was utilized in a study by Fader et al30 was used to grade the severity of IAD. The visual scale gives a score from 0 to 4; a score of 0 indicates no erythema, 1 indicates mild erythema, 2 indicates moderate erythema, 3 indicates more intense erythema, and 4 indicates broken, abraded skin. In this study, a score of 1 was considered IAD.30 These evaluations were approved by the fourth author (a dermatologist) on the study team.
Seven (7) measurement sites assessed included the sacrum, left buttock, right buttock, right groin, left groin, left thigh, and right thigh. To evaluate skin integrity, patient perineal skin condition was observed and recorded daily by the first researcher using the Perineal Skin Integrity Assessment Form. The number of defecations were observed and recorded daily on the Patient Observation Form. The main study outcomes were IAD, defined as an erythema score of 1 or more in the skin of the buttock, sacrum, thigh, and groin. Patients who developed IAD were dismissed from the study and control diaper groups, and treatment with an ointment containing Hamamelis virginiana (witch hazel) distillate was ordered by the physician.
Ethical considerations. This study was formally approved by the Turkish Ministry of Health and the ethics committee of the hospital. Insurance policies were prepared for each patient attending the study (Number 481360). Information about the research was given to the patients who met the criteria or to their relatives, and written informed consent to participate in the study was obtained.
Data analysis. Data were collected from the perineal skin integrity assessment form and patient observation form and manually entered into and analyzed using IBM SPSS Statistics, version 22 (IBM Corp, Armonk, NY) software. Statistical significance was accepted as P <.05. In order to denote IAD severity, the number of dermatitis areas and the number of days at which dermatitis occurred were tabulated. The Fisher exact test and the chi-squared test were used to evaluate the difference in the incidence of IAD between the 2 groups, and the Mann-Whitney U test was used to detect any significant differences in the number of defecations and the consistency of feces between the 2 groups.