Evaluation of a New Elastic Ostomy Appliance to Decrease Skin Complications: Results of a Pilot Study

Peristomal skin complications due to appliance leakage frequently occur in all types of ostomies, resulting in great emotional, social, and financial impact for patients. PURPOSE: This pilot study was conducted to evaluate the safety and use of a new, reusable, nonadherent, elastic device. METHOD: A convenience sample of nonhospitalized patients with ileostomies and colostomies was recruited through the Dutch ostomy patient association. Participant inclusion criteria stipulated the presence of ileostomy or colostomy, a body mass index (BMI) between 18 and 30, and presence of an osto-my for at least 1 month. Patients with existing prolapse or necrosis of the ostomy, inability to give consent, or concurrent usage of other aids to prevent leakage or skin problems were excluded. Participants were fitted with and asked to wear the appliance continuously for 4 weeks and report experiences in a structured diary. Patient charts were reviewed for baseline demographic characteristics that included age, gender, American Society of Anaesthesiologists classification, and BMI. Study nurses performed structured weekly interviews and inspections of the ostomies and peristomal skin. The primary outcome measure was occurrence of serious adverse events such as ostomy necrosis or perforation. Secondary outcome measures were patient reported incidents of leakage and satisfaction during wear and changing of the appli-ance. Peristomal skin complications also were recorded. Descriptive statistics were used to analyze results. In addition, subgroup analysis of patients with a parastomal hernia was performed because of the potential benefits of the device design in these cases. RESULTS: Participants included 23 patients (16 with colostomies, 7 with ileostomies); 13 participants (57%) were female. Mean age and BMI were 64 years and 28.3, respectively. Six (6) patients had a parastomal hernia. Due to shifting or discomfort while wearing the appliance, 16 participants discontinued use before the end of the study and were excluded from analysis from the point they left the study. Mean duration of participation was 12.8 days. No adverse events occurred. Mean number of incidents of leakage/week decreased from 3.5 ± 4.9 at start of the study to 1.8 ± 1.3  at week 4. The mean number of pouches used/week decreased from 10.5 ± 5.4 to 8 ± 2.6. Peristomal skin reactions present in 15 patients at start of the study decreased to 1 patient at the end of the study. Patient satisfaction did not change over the course of the study. Patients with parastomal hernias had similar results. CONCLUSION: No serious adverse events were reported and leakage and skin irritation were found to improve, but participant dropout rate was high and average usage time was only 12.8 days, which limited interpretation of the results. The data suggest that the appliance may offer an (intermittent) alternative to existing ostomy materials for patients experiencing troublesome leakages, peristomal skin problems, or parastomal hernias, but further research is needed to explore these outcomes. 

In The Netherlands, approximately 38 000 patients have a small or large bowel enterostomy, and each year more than 5500 new colostomies are created.1 Peri-stomal skin complications are disorders of the peristomal skin that range from mild erythema to erosions or ulcerations. Peristomal skin complications are known to present challenges related to their high incidence, negative impact on quality of life, and associated costs.

According to a recent systematic re-view by Malik et al,2 peristomal skin complications are the most frequent complication associated with ostomies; they occur in 2.4% to 46.2% of ostomies. In a retrospective analysis by Shiraishi et al3 of 333 consecutive patients who had an intestinal ostomy created in a single Japanese center, an incidence of up to 78.6% was reported. Peristomal skin complications put a high emotional and social burden on patients. A recent Dutch survey4 among patients with ostomies found that even though quality of life with an ostomy is generally acceptable, peristomal com-plications and leakage are important limiting factors to an optimal quality of life. The negative effects of peristomal skin complications on quality of life also have been described in several other international studies that include large cross-sectional surveys with more than 2000 included participants and a small-er prospective observational study of 37 patients.5-8 

Peristomal skin complications also place a considerable financial burden on individual patients and society in general. In a retrospective study that included 168 patients with all types of ostomies, Taneja et al9 found that in patients with peristomal skin complications within 120 days after surgery, the mean health care costs were approximately $8000 higher when compared to patients without skin complications.

The etiology of skin-related ostomy complications is multifactorial: con-tact dermatitis can develop because of bowel effluent leakage, injury can occur due to mechanical pressure or friction, bacterial or fungal local infections can cause peristomal skin complications, and rare allergic reactions to ostomy adhesives can contribute to the development of skin lesions.10,11 

The location of an ostomy determines the ease or difficulty of stoma care. In a review of surgical strategies to improve ostomy formation, Strong12 described the ideal location of an ostomy as the superior aspect of the infraumbilical fat mound, visible to the patient, positioned below the belt line, and surrounded by a relatively flat surface 5 cm to 7 cm in diameter. According to a retrospective study of 105 patients by Per-son et al,13 preoperatively marking the ostomy site with these considerations in mind leads to a significantly improved quality of life and decrease in complications. An improperly located ostomy at skin folds or scars may contribute to leakage and lead to additional difficulties in positioning and application of ostomy materials.2 Bulging or folding skin due to the presence of parastomal herniation further predisposes to skin complications. 

The location and protrusion of ostomies cannot be changed after creation without surgical revision, but improved ostomy materials may decrease leak-age and subsequently increase patient comfort. A new type of ostomy appliance (TOMAS, TOMAS LTD) consists of a synthetic adapter with a convex oval shape that is placed over the ostomy. The adaptor functions as a flange to which enterostomy pouches can be connected in the same way as other 2-piece ostomy systems. An O-shaped, cellulose-based absorbent gauze is placed between the skin surrounding the ostomy and the adapter. A polyes-ter-based elastic waistband is integrat-ed in the adapter. No adhesive is used to affix the adapter or waistband. The convex shape, in combination with the tight-fitting elastic waistband, keeps the material in place, while the gauze absorbs any fluids that are not collect-ed in the pouch (see Figure 1).

A pilot study was performed to assess the safety and use of this device. The primary outcome measure was occurrence of serious adverse events such as ostomy necrosis or perforation. Secondary outcome measures were occurrence of leakage, presence and resolution of peristomal skin complications, and patient satisfaction with the device. 

Ethical concerns. The ethical review boards of the Maastricht University Hospital and the Dutch Health Care Inspectorate approved this study. Assigning each participant a unique study number, which was referenced in all forms and the database, ensured patient confidentiality and anonymity. Thus, the anonymized study forms could not be traced back to participants.

Patient eligibility. A nationwide convenience sample of participants was recruited; invitations to participate were extended through newsletters and social media of the Dutch enterostomy patient association, as well as via outpatient consultations at the authors’ clinic. Inclusion criteria were presence of ileostomy or colostomy, a body mass index (BMI) between 18 and 30, and presence of an ostomy for at least 1 month. Patients with preexisting peristomal skin complications was a factor for inclusion in the study, because the main goal of the study was to evaluate the safety of the product. Patients with major prolapse or necrosis of the ostomy, inability to consent to participation of the study, or current usage of other aids to prevent leakage or skin problems, as well as hospitalized patients, were not eligible for inclusion in the study.

The study was conducted from April 1, 2018, to September 30, 2018. After written consent was obtained, a specialized ostomy nurse fit all participants with the ostomy waistband after taking baseline measurements. The ostomy care nurse received training from the appliance manufacturer regarding the correct fitting and adjustment of the appliance, as well as training in patient counseling on correct use of the appliance. If necessary, an ostomy nurse adjusted the belt during the study; reasons for adjustment of the appliance included loose fit with shifting or leakage or a tight fit that caused the participant pain or discomfort. 

Participants were instructed to wear the appliance continuously for 4 weeks. The appliance was removed for bathing. The absorbing gauze was to be changed daily or earlier if fully saturated. Participants were allowed to continue their usual daily activities. 

Patient characteristics assessed. Baseline characteristics documented at the start of the study included gender, age, BMI, the American Society of Anesthesiologists (ASA) classification, and the presence of a parastomal hernia.

Participants were assigned a unique study number. During the study period, patients kept a written diary to record their experiences. Structured interviews and physical examination of the ostomy were performed by 2 ostomy nurses before the start of the study and each consecutive week thereafter during outpatient clinic visits. 

Primary outcome measures. The primary outcome measure of this pilot study was occurrence of serious adverse events such as ostomy necrosis or perforation, which would lead to immediate cessation of belt use and optimum treatment as determined by the attending physician. If a patient discontinued participation before completion of the study, the time and reason were recorded. 

Secondary outcome measures. Secondary outcome measures included occurrence and frequency of leakage, ostomy-related skin problems, and frequency of change of ostomy pouches. If present, skin problems were categorized as erythema, erosion, bleeding, or other reactions. 

Patients reported satisfaction with regard to comfort experienced during changing of the materials and during daily use; other subjective experiences during usage also were scored. Satisfaction with the appliance and emotional and personal impact of these materials were recorded at the start of the study at subsequent weekly clinic visits using a 10-point Likert scale where 1 was defined as very uncomfortable and 10 as very comfortable. 

The structured interviews and physical examination of the ostomy were performed before the start of the study and each consecutive week thereafter in the outpatient clinic. The patient diaries were reviewed and discussed, and the stoma and peristomal skin were inspected during these visits. Findings were reported in standardized study forms. 

Data collection and analysis. During the study period, patients kept a written diary to record their experiences. In addition to a description of their experiences during use of the appliance, the participants were queried specifically on several topics. Patients were asked to note in the study form each incident of leakage, the number of pouches and gauzes used, and comfort during wear and change of the appliance, the ostomy pouch, and the protective gauze. Patients also were asked to describe/categorize peristomal skin complications if present. 

The data forms and written patient diaries were processed anonymously into an electronic dataset by the authors who were blinded regarding patient identity. The same authors performed the data analysis. The responses to the questions were coded and entered into the SPSS software package (SPSS Statistics for Windows, version 22 (IBM Corp). Narrative aspects of the diaries were analyzed, and the number of common responses were noted. Patients who discontinued the study before the planned endpoint of 4 weeks were excluded from analysis from the date they left the study. 

Statistical analysis included Student’s t test and chi-squared test to assess differences in baseline characteristics among participants, and the Wilcoxon signed rank test to detect significance of differences in repeated measures as the study progressed. A P value less than .05 was considered statistically significant. 

Of note: Because the new appliance combines an ostomy appliance with the features of a hernia support truss, patients with a parastomal hernia potentially have larger benefits from the new materials. Therefore, a subgroup analysis was performed for participants with a parastomal hernia. 

Of the 23 patients enrolled (13 female [57%], mean age 64 [range 36–81] years), 16 had a colostomy (70%) and 7 had an ileostomy (all ostomies were permanent). Mean BMI was 28.3. Fourteen (14) patients (61%) had an ASA classification II. No significant differences in baseline characteristics were found. Among the 6 participants with a parastomal hernia, 1 had an ileostomy and 5 had a colostomy (see Table 1). 

Sixteen (16) participants left the study early. Of the 7 patients who wore the appliance for 4 weeks, 5 (31.3% of colostomy participants) had a colostomy and 2 (28.6% of ileostomy participants) had an ileostomy. The dropout rate did not differ significantly by stoma type. 

Participants wore the appliance for a mean of 12.8 (range 1–28) days; persons with colostomies wore the appliance for 14 days, persons with ileostomies for 10 days, and persons with parastomal hernias for 15.2 days). 

Reasons for early cessation of participation in the study or for intermittent wear of the appliance varied: patients reported more smell or flatus (6 patients), discomfort due to tightness of the elastic waistband (4 patients), occurrence of nighttime leakages due to movement of the bandage (9 patients), or a combination of the reasons above. In nearly all patients, the girdle had to be adjusted at least once to achieve comfort while maintaining acceptable fixation of the adapter around the ostomy.

Primary outcome measure. No serious adverse events such as necrosis or perforation were observed among the participants during the study. One (1) patient with preexisting prolapse of the ostomy was seen at the emergency department of a nearby hospital because of swelling and edema and was advised to discontinue participation. After removal of the appliance, these complaints diminished quickly. No friction or pressure injuries leading to peristomal skin complications were detected. 

Secondary outcome measures.

Leakage and skin reactions. During the study, the mean number of leakage incidents decreased from 3.5 ± 4.9 per week before the study (baseline) to 1.8 ± 1.3 per week among the participants at the end of the study (see Table 2). The Wilcoxon signed rank test found a significant decrease between baseline number of incidents of leakage per week and number of leakages at 2 weeks of participation (mean duration of participation) in this interval (Z = 53;  P <.001). 

Skin reactions also decreased the longer patients wore the appliance (see Table 2). At baseline, 15 patients (65%) reported skin reactions, ranging from erythema to erosions and bleeding. At the conclusion of the study, only 1 out of the 7 patients reported skin erythema (14.3%). Four (4) of these 7 patients started the study with peristomal skin complication (2 patients had erythema, 1 patient had skin erosions, and 1 patient had peristomal skin bleeding).  

Most participants showed a decrease in use of collection pouches during the study when compared to baseline measurements; the mean number of pouches used weekly decreased from 10.5 ± 5.4 at baseline to 8.0 ± 2.6 at the end of the study without reaching statistical significance (see Table 2). 

Patient reported satisfaction. Baseline data on comfort at the start of the study and during use remained constant (7.1 ± 1.6 and 7.3 ± 1.0, respectively). Final mean satisfaction scores among the 7 patients regarding changing the device were similar to baseline measurement at the start of the study (7.8 ± 1.7 and 6.7 ± 2.1, respectively). 

Among the 12 patients (52%) who reported edema and increase in size of the stoma compared to the start of the study, 5 stopped wearing the appliance or started to wear it intermittently.

Participants reported the following positive aspects of the appliance in their diaries: ease of use (5 patients, 21.7%), the possibility to omit adhesive materials to allow application of topical ointment on skin lesions (3 patients, 13%), and a comfortable tight fit of the waistband (5 patients, 21.7%).

Reported disadvantages included the tight fit around the waist, which was reported to be corset-like (13 patients, 56.5%), the possibility of girdle shift if the appliance was not adjusted correctly (7 patients, 30.4%), and an increase in noticeable flatus and smells (2 patients, 8.7%). 

Parastomal hernia. Of the 6 participants with a parastomal hernia, 2 (both with a colostomy) completed the study. Participants with a parastomal hernia showed a decrease in frequency of leakage: at baseline, the mean number of incidents of leakage per week was 1.7 ± 1.6, which decreased to 0.2 ± 0.7 at the end of the study. At the start of the study, 4 patients with a parastomal hernia had skin erythema, and 2 patients had erosions surrounding the ostomy. Although 1 of the patients with erythema had progression of erythema to erosions in the first week of use, by the fourth week, skin irritations had resolved in the remaining participating patients with a parastomal hernia. 

The quantity of collection pouches used decreased during the study. The baseline number of appliances used was 15 ± 6.7 per week, decreasing to 7 ± 0 in the final week.

The mean patient reported satisfaction score during use of the appliance showed an increase from baseline to the final week (5.8 ± 1.3 to 8 ± 0) in patients with parastomal herniations. Mean satisfaction scores with change of materials increased from 6.75 ± 1.5 at baseline to 8 in the third week; the final satisfaction score was 5.5 ± 3.5. 

Participants with a parastomal hernia reported an increase of smells and flatus. While other participants reported the belt’s tight fit was a disadvantage, patients with a parastomal herniation described this is a major advantage of the device. 

This was the first pilot study to evaluate the safety and use of this new ostomy appliance. No adverse events occurred, and in patients who completed the study, incidents of leakage and skin lesions decreased, as well as quantity of used pouches, including among persons with parastomal hernias. These results suggest that the appliance may be suited for temporary or intermittent use in patients with a parastomal hernia or frequent leakage and peristomal skin complications, possibly because the omission of applications and adhesives allows the peristomal skin to heal. However, more than half of all participants did not complete the 4 week study. 

Participants were generally satisfied with their current appliances and participated in this study to help develop new solutions for fellow ostomy patients who have frequent leakage and peristomal skin erosions. Almost all participants experienced considerable early discomfort during use of the device as well as early leakage. These factors improved with adjustment of the appliance and familiarization with the use and feeling of the tight elastic bandage around the waist. Despite participant motivations for engaging in the study, this early setback induced early cessation of participation for some patients. As seen in the results, participants who continued after this initial adjustment or learning curve reported an improvement in comfort and satisfaction. Noticeably, patients with a parastomal hernia considered the tight fit of the appliance an advantage of the system, possibly because the appliance combines ostomy materials with the function of a hernia bandage. 

A potential target population for use of the appliance may be patients with allergic peristomal contact dermatitis. A recent retrospective review by Cressey et al¹⁴ posits that allergy to stoma products may be more prevalent than previously thought. In a selected population of 54 patients who were treated by a dermatologist for peristomal dermatitis, 12 out of 18 patients (66.7%) with active dermatitis had positive allergy testing to stoma care products. Further study in a general ostomy population is needed to verify these findings. If allergic peristomal skin complications due to adhesives are more common than previously thought, the new appliance may offer an alternative for these patients.

Until now, most attention in research for prevention and management of peristomal skin problems has focused on the material of the flanges and on different barrier creams, lotions, or sprays that prevent the skin from coming into contact with the irritating ostomy effluent.^15,16 One disadvantage of these products is that they have to be affixed to the skin and subsequently removed. This risks damaging the peristomal skin due to mechanical friction or chemical injury. To the author’s knowledge, the study appliance is the first ostomy system in recent history that negates this risk by omitting the need for application of adhesives and therefor the risk of skin injury. The appliance represents a return, in updated form, to belt-like reusable systems that were the only appliances available until the introduction of adhesive systems with karaya gum in 1960 and hydrocolloid stomahesive in 1970.  

The appliance also may decrease the economic burden of ostomy materials and ostomy-related skin complications for patients and health care systems by utilizing a reusable adaptor and elastic bandage. The slight decrease in ostomy pouch usage may offer some reduction in costs. However, the foremost potential economic benefit may be from preventing peristomal skin problems. Taneja et al⁹ found an approximate extra cost of $8000 for readmissions, extra outpatient visits, and material costs in patients with peristomal skin complications. In their retrospective assessment of data, Meisner et al¹⁷ also noted increased cost; a 7-week treatment period (including appliances and accessories) was €263 for a patient with peristomal skin complication compared with €215 for persons without skin complications. Their cost analysis was based on a treatment algorithm that utilized the dataset of the Dialogue Study,¹⁸ an open-label, noncomparative, multinational study that documented real-life experiences of stoma care in 3017 participants. 

More prospective observational research is needed on this new appliance to verify the findings of this pilot study, preferably in comparison with existing ostomy systems. Future studies may help ascertain optimal target groups, usage criteria, and indications. Such studies also will need to focus on patient selection and counselling on use of the system before inclusion in a study to prevent high dropout rates. Adapting the system, such as changing the width of the elastic waistband or inserting rigid parts in the waistband akin to bones in a corset, may increase comfort. 

The most important limitation of the study that should be considered when interpreting the results is the small sample size and high dropout rate of participants. 

Another limitation of the study is the wide range of participant BMI (19 to 36.7).  Obesity is a known risk factor for increased postoperative complications in general.¹⁹ As found in both prospective and retrospective observational cohort studies,^20-22 complications such as ostomy retraction and parastomal hernia development occur more frequently in obese patients. A recent German observational study by Braumann et al²³ also found a higher rate of peristomal skin complications in obese compared to nonobese patients. Although obese patients potentially may benefit more from the appliance, their obesity may decrease comfort and tolerance of the device; the presence of skinfolds and curves may induce leakages and shifting, which require tighter fitting of the elastic waistband. 

This 4-week pilot study involving 23 ileostomy and colostomy patients evaluated the safety and use of a new ostomy appliance that employs an elastic waistband connected to a synthetic adapter around the ostomy. No adverse events were reported in the study. Among the 7 participants who completed the study, leakage and peristomal skin problems appeared to improve with use. The study experienced a high participant dropout rate, which limited the interpretation of results. However, results suggest that the appliance has the potential to offer an alternative to existing ostomy materials for patients experiencing troublesome leakages, peristomal skin problems, or parastomal hernias. Future studies should focus on these patient groups. 

Ostomy appliances were provided by TOMAS LTD for this safety and feasibility pi-lot study. The appliance is a proprietary product of TOMAS LTD. None of the authors have any current or potential future financial interest in the product. 

Dr. Bloemen is a surgical resident and Dr. Aarts is a consultant surgeon, Department of Surgery, VieCuri Medical Centre, Venlo, The Netherlands. Dr. Bouvy is a professor of surgery, Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands. Dr. Nijhuis is a consultant surgeon, Department of Surgery, VieCuri Medical Centre. Please address correspondence to: Arthur Bloemen MD, VieCuri Medical Centre, Department of General Surgery, Tegelseweg 210, 5912 BL Venlo, The Netherlands; email: arthurbloemen@hotmail.nl.