The Effects of Using a Moldable Skin Barrier on Peristomal Skin Condition in Persons with an Ostomy: Results of a Prospective, Observational, Multinational Study

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Ostomy Wound Manage. 2014;60(12):16–26.
Maria Teresa Szewczyk, MD, PhD; Grazyna Majewska, RN, ETN; Mary V. Cabral, MS, FNP-BC, CWOCN-AP; and Karin Hölzel-Piontek, RN

Abstract

  Peristomal skin problems are the most commonly experienced physical complication following ostomy surgery and often are caused by leakage or a poorly fitting skin barrier. A prospective, multicenter, observational evaluation of persons with a colostomy, ileostomy, or urostomy was conducted to assess the incidence of peristomal lesions and level of patient satisfaction with moldable skin barriers.

  Peristomal skin was assessed using the Studio Alterazoni Cutanee Stomale (SACS™) scale, and patients were asked to rate barrier application and usage variables. During a period of 12 months, and using convenience sampling, 561 patients from 90 centers in 3 countries were enrolled: 28 in Germany, 48 in Poland, and 14 in the United States. Participants included 277 new stoma patients (average time since surgery 0.3 months; average age 64.7 ± 12.86 years) who had a colostomy (174), ileostomy (72), or urostomy (10); and 284 patients with an existing stoma (average time since surgery 18.2 months; average age 66 ± 12.62 years) who had a colostomy (174), ileostomy (88), or urostomy (22) who experienced skin complications using a traditional skin barrier (ie, a solid or flexible barrier with precut opening or one requiring cutting an opening to accommodate the stoma). All patients were assessed at baseline and after 1 and 2 months. In the patients with a new stoma, 225 (90.4%) had intact skin at baseline, 239 (95.6%) had intact skin after 2 months, and 98% rated overall satisfaction with the barrier as good or excellent. In the patients with an existing stoma, intact skin was observed in 103 patients (39.5%) at baseline and 225 (86.2%) after 2 months, with 96.5% of patients rating overall satisfaction with the barrier as good or excellent. In this group, the proportion of patients who used accessory products (eg, belt, deodorants, powder) was 73% at baseline and 64.2% at the 2-month follow-up. The moldable skin barriers evaluated were effective in preventing and healing peristomal skin complications and were rated as good or excellent by the vast majority of patients. Comparative studies are warranted to evaluate the efficacy and cost-effectiveness of this moldable skin barrier.

Potential Conflicts of Interest: Funding for this research was provided by ConvaTec Inc, Skillman, NJ.

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RELATED CONTENT
A Prospective Multicenter Evaluation of a Moldable Stoma Skin Barrier
Peristomal Skin Complications: Prevention and Management 
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Introduction

  Surgical creation of a stoma to allow discharge of body waste products is often a necessary component of treatment for several medical conditions such as colorectal cancer, bladder cancer, and inflammatory bowel disease. Ostomy surgery is common: in the United Kingdom, approximately 102,000 patients have a permanent stoma1; in the United States an estimated 450,000+ patients have a stoma and an additional 120,000 patients undergo ostomy surgery every year.2 As a result of this life-altering procedure, ostomy patients can experience multiple physical and psychosocial challenges as they adjust to life and the use of an ostomy device to facilitate a sensitive bodily function.

  Among the many challenges faced by persons with a stoma is the risk of developing complications relating to the skin around the stoma. Early complications (those that occur during the first 2 weeks after surgery) include edema, bleeding, ischemia, intra-and peristomal necrosis, restrictions, retraction or dehiscence of the mucosal-cutaneous junction, suppuration or peristomal abscess, complications due to poor positioning, acute dermatitis, and skin lesions. Delayed complications (those that occur 15 days or more postsurgery) include hernia, prolapses, fistula, granulomatous stenosis, folliculitis, trauma, hemorrhage, and chronic dermatitis.3 Research demonstrates peristomal skin complications are the most commonly experienced physical complication following ostomy surgery,4 affecting 45% to 68% of long-term ostomates.1,5-7 Herlusfsen et al’s1 cross-sectional study investigated frequency and severity of peristomal skin disorders among individuals with a permanent stoma from a colostomy, ileostomy, or urostomy and found a high frequency of peristomal disorders, 77% of skin issues related to contact with stoma effluent. Bosio et al’s5 prospective, observational study recognized the need for a tool to classify peristomal skin disorders; the authors conducted a study among 8 ostomy centers across Italy, including 7 enterostomal nurses and 4 surgeons, using information from 800 digital photographs and blood samples from 339 patients to create an instrument to facilitate lesion interpretation and detection. In an open-labeled, noncomparative multicenter study among 743 persons with a colostomy, ileostomy, or urostomy, Erwin-Toth et al6 evaluated peristomal skin condition and quality of life and concluded regular contact with a wound ostomy continence (WOC) nurse specialist and use of a double-layer adhesive appliance led to a significant reduction in leakage and accessory use with improved skin condition and improvement in health-related quality of life. In a multicenter, descriptive study conducted among 80 persons with a colostomy, ileostomy, or urostomy, Williams et al7 used structured questionnaires and interviews by stoma nurse specialists to identify actual and potential skin problems regarding use of different types of stoma appliances and accessories and concluded skin problems are common, and the differences found between patient and nurse perception of peristomal skin conditions helped identify the educational needs of patients with a new stoma, including education and regular follow-up by an ostomy specialist. In several of these studies,1,5,7 results revealed a high frequency of peristomal skin disorders with many of the participants failing to perceive the presence of skin irritation, and all studies identified the importance of early and continuous education with a stoma nurse specialist.

  The majority of stoma complications are related to leakage,1,5 which allows effluent to come into contact with the skin. A skin barrier, which attaches the ostomy pouch to the abdomen, is designed to protect the skin from stomal output, but an ill-fitting barrier can allow effluent to come into contact with the skin, causing peristomal skin breakdown. A person with a stoma who develops compromised peristomal skin can experience a vicious cycle of suboptimal barrier adhesion, continual leakage, and further peristomal skin breakdown. Accordingly, healthy peristomal skin is essential to achieving a secure seal between the barrier and the peristomal skin; conversely, a secure seal is essential to preventing leakage and maintaining healthy peristomal skin. Using a convenience sample, Hoeflok et al8 conducted a prospective multicenter evaluation among 60 Canadian enterostomal therapy nurses and 172 persons with a stoma to evaluate moldable skin barriers, including ease of application and use, ease of teaching, effective skin protection, and ease of barrier application and found the barriers to be comfortable and easy to use.

  In addition to compromised peristomal skin, persons with a stoma also may face psychosocial and quality-of-life issues9 including altered body image, lifestyle changes, and reduced quality of life. Nordstrom and Nyman10 investigated 44 patients who underwent ileal conduit surgery for bladder cancer and 22 patients who underwent the same procedure for urinary incontinence or dysfunction. Stoma-related problems, including stoma and skin complications, eventually caused 20% of patients to become completely disabled. Quality of life was impacted because the bladder cancer patients more frequently curtailed their social activities, including a decrease in sexual activity. Pouch leakage also can be a source of anxiety, especially in persons with a colostomy or ileostomy where fear of odor can be an issue. Leakage also can have a negative impact on quality of life and can lead to peristomal skin complications, which are a burden on the patient as well as the health care system that must provide ongoing care.3 An ostomy system that is comfortable, easy to use, and provides security from leaks will help ease the transition for new ostomy patients and help reduce the risk and burden of peristomal skin complications.

  Standard ostomy barriers (eg, cut-to-fit and precut) used to help maintain the ostomy appliance/skin seal and prevent leakage require the patient to master complex skills. The barriers may not fit precisely, leaving exposed skin subject to the risk of breakdown, and the rough edges on cut-to-fit barriers may cause mechanical trauma to the stoma.9 ConvaTec Moldable Technology™ Skin Barriers (ConvaTec Inc, Skillman, NJ) were developed to provide easy application and a customized fit around the stoma for a more secure seal. The barrier is fitted to an individual stoma by rolling the moldable barrier to the approximate stoma size, applying the barrier to the body, and rolling back the moldable barrier so it securely hugs the base of the stoma. The moldable barrier allows a personalized fit, with improved adhesion onto irregular skin surfaces and around irregularly shaped stomas; two types of moldable barriers accommodate a flat or convex wafer support system. Skin contact layers may use either regular- or extended-wear adhesive. Both wafers are available in small, medium, large, and extra large. In a Canadian, multicenter, prospective evaluation,8 172 patients and 49 enterostomal therapists reported moldable skin barriers were easy to use, easy to learn to apply, easy to teach to apply, and provided a secure fit. A pilot study11,12 was conducted in France from June 2010 to March 2011 in which 786 patients, including new patients (ostomy surgery within 7 days) and stoma patients with preexisting skin conditions, were evaluated for 2 months. The study demonstrated moldable skin barriers helped maintain peristomal skin integrity and improved skin condition in patients with existing lesions and were rated high in patient satisfaction.

  To further assess the performance of moldable skin barriers, a global prospective, multicenter, observational study was conducted to determine the incidence of peristomal lesions, evaluate the progression of peristomal skin condition at 8 to 15 days following the application of the skin barrier, and assess level of satisfaction with these products in patients with new ostomies (surgery within the past 7 days) and in patients with existing ostomies (patients already using an ostomy system) who experienced skin complications with traditional barriers.

Methods and Procedures

  Study centers and participants. The study was initiated at 90 centers: 48 in Poland, 28 in Germany, and 14 in the US. Investigators all were either hospital- or community-based stoma care specialists. Inclusion criteria stipulated patients should be 18 years or older with an ileostomy, colostomy, or urostomy and they should use a moldable skin barrier as the first (within 7 days of surgery) long-term system; or, in persons who presented with peristomal skin lesions using a traditional barrier, who agreed to replace the traditional barrier with a moldable skin barrier in the context of routine clinical care. Patients with cognitive issues that would prevent them from answering a questionnaire or who would be unable to complete study evaluations were ineligible to participate. Participants were recruited while in the acute care setting or clinic setting post hospital discharge. Convenience sampling was utilized.

  Participants agreed to provide signed informed consent before any protocol-required procedures were performed, including any procedures not part of normal patient care. Treatments that could affect the condition of the skin, including barrier failure, chemotherapy and/or radiotherapy, were recorded at baseline and at each assessment. The informed consent document was used to explain the potential risks and benefits of participation before evaluation commenced. The investigator collected the demographic and clinical information, and each person’s stoma was assessed; peristomal skin condition was classified using the Studio Alterazoni Cutanee Stomale (Study on Peristomal Skin lesions, SACS™) Instrument.13 The SACS™ scale is an objective classification system developed and accepted by consensus of health care professionals in Italy. It subsequently has been validated in both Italy and the US (content validity of 0.94 out of 1.014). This system classifies skin lesions in 2 dimensions: lesion type and topographical location. Lesion type was rated in order of increasing severity as hyperemic (presence of excess blood in the vessels), erosive (gradual destruction of surface tissue), ulcerative (open wound), ulcerative fibrinonecrotic (avascular), or proliferative (collagen synthesis, cell proliferation/extracellular matrix formation).15 Lesion topography was described by peristomal quadrant: upper right, lower right, lower left, upper left, or all peristomal quadrants.

  The study was conducted among 2 cohorts: the first cohort (Group A) included new patients with intact skin who used moldable skin barriers as the first long-term system after ostomy surgery (within 7 days). The second cohort (Group B) included patients already using an ostomy system who presented with peristomal skin lesions and for whom a decision was made in the context of routine clinical care to replace the traditional skin barrier (1-piece or 2-piece standard or 2-piece adhesive) with the study products. The molding layer used was the extended wear adhesive for both types of skin barrier.

  Ethical considerations. This observational study was conducted in accordance with procedures intended to ensure adherence to the Good Clinical Practice. Approval was obtained from an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) before initiating the study in each study center.

  Study treatments. After enrollment, all patients used moldable skin barriers, which were routinely changed by the patient according to the site’s standard teaching instructions. The moldable skin barriers used were either Esteem synergy® (ES) or SUR-FIT Natura®/Combihesive® (SF) (ConvaTec, Skillman, NJ). Barrier selection was at the discretion of the investigator. The skin contact layer is made of either Stomahesive® (Regular Wear) adhesive or Durahesive® (Extended wear) adhesive, and the molding layer is made of Durahesive® adhesive for both products. Both types of barrier are available as flat or convex wafer systems and are available in small, medium, large, and extra-large (oval) sizes. Moldable skin barriers were replaced routinely and/or if leakage occurred.

  Blinding was not applicable because this was an observational study in which all participants used the same product type.

  Study assessments. Data were collected via case report forms at baseline, at 8 to 15 days following enrollment, at 1 month (± 15 days) following enrollment, and at 2 months (±15 days) following enrollment. Groups A and B followed the same schedule of study procedures. After informed consent was obtained, baseline demographics were collected, which included date of stoma surgery, type of stoma, stoma shape, stoma appearance, stoma state (temporary or permanent), stool characteristics, and accessory usage. Information on the stoma system used before study enrollment and reason for change in barrier type was collected for Group B. Peristomal skin condition was assessed at baseline and at each follow-up visit using the validated SACS™ Instrument.13 The progression of the peristomal skin condition was evaluated by comparing SACS™ assessment at each follow-up visit to the baseline SACS™ assessment, along with usual reason for barrier change, stool characteristics, and accessory usage (ie, use of powder, belts, paste, deodorant/odor control products, and adhesive remover wipes).

  Patients evaluated the performance of the moldable skin barrier at each follow-up visit by completing a Satisfaction Questionnaire which rated comfort, ease of molding, ease of application and removal, level of confidence, and overall performance of the skin barrier. The 4 response options were excellent, good, poor, and very poor. Patients also rated their satisfaction using the validated Mirror Questionnaire,16 which was completed 1 and 2 months after baseline assessment independently by the participant without assistance or intervention by the investigator. The Mirror Questionnaire consisted of 13 questions assessing patient satisfaction with the ostomy system and medical care received. Patients rated their responses as very satisfied, relatively satisfied, satisfied, not very satisfied, and not at all satisfied using values from 1 (very satisfied) to 5 (not at all satisfied). Patients also rated the relative importance of 5 skin barrier characteristics (ease of changing the skin barrier or pouch, adherence of the skin barrier or pouch, number of times the skin barrier needed to be changed, secureness of the skin barrier or pouch, and protection of the skin at the site of the skin barrier or pouch). Additionally, 4 points of information provided to the patient and/or family by medical staff on diet, training and instruction regarding how to handle the skin barrier or pouch, and how to contact the medical staff if the patient had any questions were ranked from 1 (most important) to 4 or 5 (least important). The Mirror Questionnaires were collected during the study visit or by mail; questionnaires were to be completed at 1 and 2 months after baseline and returned at assessment 2 and 3 or sent to the sponsoring company (ConvaTec) directly by mail if no follow-up visit was scheduled. Preaddressed and stamped envelopes were provided for this purpose. Both the Mirror Questionnaire and the SACS™ tool were translated into local languages.

  Data and statistical analysis. All data were recorded on the case report forms and data entry verified by double key entry. Data analysis was performed with statistics software SAS version 9.2 for Windows (SAS Institute Inc, Cary, NC). All primary and secondary parameters reported were summarized according to evaluation group (A and B) and stoma type (ileostomy, colostomy, or urostomy). Continuous variables such as age, gender, and stoma characteristics were summarized by mean, standard deviation, median, percentile 25, percentile 75, and number of valid cases. Categorical variables such as incidence of skin lesions and participant evaluations were described as the total number, relative percentage of participants per response category, and 95% confidence interval. Summaries were reported according to the predefined evaluation subgroups.

 Populations for analysis were the intent-to-treat population (ITT), which included all enrolled participants who used a moldable skin barrier, and the analyzable population, defined as participants who completed each of the follow-up visits. Any adverse events, device malfunctions, or complaints that occurred during the evaluation were reported to the Study Center according to normal procedures and documented in the medical record. Statistical significance was determined for improvement in patient satisfaction in Group B (Mirror Questionnaire) (P <0.001).

Results

  Participant demographics and stoma characteristics. A total of 623 patients were enrolled from 67 centers in Germany, Poland, and the US. Sixty-two (62) patients were not included in the analyzable population because they failed to meet the inclusion criteria, did not report stoma type, or were enrolled in Group B even though their skin condition was normal. To provide the most conservative assessment, patients enrolled in Group A with abnormal peristomal skin at baseline were not excluded from the analysis. A total of 551 patients were included in the study population — 277 patients in Group A and 284 patients in Group B in the intent-to-treat groups. The analyzable population consisted of 511 patients — 250 patients in Group A and 261 patients in Group B. Participants were permitted to withdraw from the evaluation at any time.

 Age and ostomy type. The mean age of patients was 64.7 ± 12.86 years in Group A and 66 ± 12.62 years in Group B. The majority of participants enrolled in both groups had a colostomy (174 [70.4%] in Group A; 174 [61.3%] in Group B), followed by ileostomy (72 [26.0%] in Group A; 88 [31.0%] in Group B), and urostomy (10 [3.6%] in Group A; 22 [7.7%]) in Group B).

 Time since stoma creation. Time from creation of the stoma to study enrollment in Group A was 0.3 months (1.43 SD), or approximately 9 days, and in Group B was 18.2 months (44.35 SD). Although patients in Group A were to be enrolled within 7 days of ostomy surgery per the study protocol, it was found that many sites did not standardly transition patients to an ostomy system within 7 days of surgery; therefore, patients in Group A could be enrolled outside of the 7-day window, provided the moldable barrier was the first permanent barrier used after surgery (see Table 1).

  Baseline stoma characteristics. The majority of stomas in both groups were permanent, round, and protruding. A 2-piece moldable skin barrier was the most common type of skin barrier applied at the baseline visit in both groups (256 [92.4%] in Group A; 259 [91.2%] in Group B) (see Table 2).

  Characteristics of the ostomy system used before study enrollment. The most frequently reported reasons for switching from the traditional barrier to the moldable barrier were to improve fit around the stoma and to avoid cutting the wafer. The majority of patients in Group B (277, 79.9%) stated they usually changed the barrier they used due to leakage (see Table 3).

  Baseline peristomal skin condition. In Group A, 228 patients (91.2%) had normal and 22 (8.8%) had abnormal peristomal skin at baseline. All patients in Group B (100%, 261) had abnormal peristomal skin at baseline. Patients could have more than one peristomal lesion, and each lesion was assessed separately using the SACS™ scale. Most baseline lesions in both the groups were of the least severe types: hyperemic (11 [4.4%] in Group A; 104 [39.8%] in Group B) and erosive (9 [3.6%] in Group A; 135 [51.7%] in Group B). Most baseline skin lesions were located in the lower right (9 [3.6%] in Group A; 103 [39.5%] in Group B) or lower left peristomal quadrants (6 [2.4%] in Group A; 124 [47.5%] in Group B), which is to be expected, because leakage from the ostomy system is more likely to come in contact with the lower peristomal quadrants. In Group B, 106 patients (40.6%) had lesions in all peristomal quadrants (see Table 4).

  Progression of peristomal skin condition. The primary outcome in this study was development of new skin lesions or worsening of preexisting lesions. Nine patients (3.6%) in Group A and 7 patients (2.7%) in Group B reported a new lesion or worsening of preexisting lesion at the 2-month follow-up visit (see Table 5).

  Patients with normal skin at the 8- to 15-day, 1-month, and 2-month follow-up visits included 225 (90.4%), 223 (89.2%), and 239 (95.6%), respectively in Group A and 103 (39.5%), 202 (77.4%), and 225 (86.2%), respectively in Group B (see Tables 6a and 6b and Figure 1). Also, the number of patients in Group B with peristomal lesions in all 4 quadrants decreased from 106 (40.6%) at baseline to 14 (5.4%) at the 2-month follow-up visit (see Figure 2).

  Patient evaluation of the moldable skin barrier. Patients assessed the comfort level, ease of preparing, ease of attaching, ease of removal, reliability, and overall perception of the moldable skin barrier in a Satisfaction Questionnaire at all follow-up visits. For patients in the analyzable population, all categories of the Satisfaction Questionnaire were rated as good or excellent by more than 95% of patients at the 1-month and 2-month follow-up visits (see Figures 3a and 3b). New patients (Group A) rated their overall satisfaction as good or excellent (99.6%, 99.6%, and 98.0% at 8-15 days, 1 month, and 2 months post-baseline, respectively). Similar satisfaction rates were seen in patients who changed from a traditional barrier to the moldable barrier (Group B), with 96.9%, 95.8%, and 96.5% of participants, respectively, rating overall satisfaction as good or excellent. New patients (Group A) rated the comfort of the moldable barrier as good or excellent by a combined percentage of 97.2% or more at each follow-up visit, and the number of patients rating comfort as excellent steadily increased at each visit (8 to 15 days: 106 [42.6%]; 1 month: 129 [51.6%]; 2 months: 138 [55.2%]) (see Figure 4). Patients in Group B with experience using other types of barriers rated the ease of preparing the moldable barrier as good or excellent by a combined percentage of 96.5% or more at each follow-up visit, and the number of patients rating ease of preparing the barrier as excellent steadily increased at each visit (8 to 15 days: 124 [47.5%]; 1 month: 158 [60.5%]; 2 months: 178 [68.2%]) (see Figure 5).

  Mirror Questionnaire. Patients rated their satisfaction with the ostomy system and medical care using the Mirror Questionnaire at the 1-month and 2-month follow-up visits (see Table 7). Overall, possible total scores could range from a minimum of 13, which would represent a response of very satisfied to all 13 questionnaire items, to a maximum of 65, which would represent a response of not at all satisfied to all questionnaire items. The mean Mirror Questionnaire score was 18.9 at 2 months for Group A and 18.1 for Group B. In both Groups A and B, patient satisfaction was higher at month 2 than at month 1; for Group B, the difference was statistically significant (P <0.001).

  The Mirror Questionnaire also includes two questions on patient preference regarding the relative importance of characteristics of the ostomy system and relative importance of the type of information provided by the medical staff. Patients in both Groups A and B combined rated Secureness of the skin barrier or pouch (so that it does not leak) at the 1-month visit as 1.9 ± 1.17 and at the 2-month visit as 1.9 ± 1.16 and Information on training and instruction on how to handle the skin barrier or pouch at 1-month visit as 1.7 ± 0.95 and at the 2-month visit as 1.8 ± 0.97 as the most important considerations.

  Usual reason for skin barrier change. The usual reason for ostomy skin barrier change was recorded at each visit. At baseline, for colostomy patients in Group B, 129 (78.2%) reported leakage, and 33 (20.0%) reported routine as the usual reason for skin barrier change. However, at 2 months, 5 (3.2%) colostomy patients reported leakage as the usual reason for skin barrier change and 152 (96.2%) reported the reason for barrier change as routine. Similar results were reported for patients with ileostomies and urostomies, with 66 (88.0%) and 14 (70.0%) of patients, respectively, at baseline and 11 (8.4%) and 1 (6.7%) at 2 months, respectively, reporting leakage as the usual reason for skin barrier change.

  Accessory use. Use of ostomy accessories such as powder, belts, paste, deodorant/odor control products, and adhesive remover wipes was recorded at each visit. The number of patients in Group B using accessories decreased after switching to the moldable skin barriers from 191 (73.7%) at baseline to 156 (64.2%) at 2 months (see Table 8). The largest differences were seen in the use of powder, which decreased from being used by 70 (27.0%) at baseline to 17 (7.0%) patients at 2 months, and in the use of deodorant/odor control products, which decreased from 48 (18.5%) at baseline to 24 (9.9%) at 2 months after switching to moldable skin barriers.

Discussion

  A well-established goal of ostomy care is to ensure a secure seal around the stoma to protect peristomal skin. Skin must be dry and intact, and the skin barrier must fit properly to ensure a secure seal and achieve a consistent, sustainable wear time. Intact peristomal skin and a properly fitted skin barrier also prevent leakage, which is a major factor in peristomal skin erosion.15 In a cross-sectional study by Herlufsen et al1 in patients with permanent stomas, the frequency of skin disorders was reported as 57% for patients with ileostomies, 48% for patients with urostomies, and 35% for patients with colostomies. For 77% of patients, contact with stoma effluent was a factor in development of skin disorders, and in 76% of the patients with peristomal skin problems, the issues took more than 3 months to resolve. Peristomal skin disorders are a prevalent, chronic issue for ostomates, and can be prevented and treated by improving barrier fit and adhesion, thereby reducing leakage. Results noted in the studies by Herlufsen et al,1 Bosio et al,5 Erwin-Toth et al,6 and Williams et al7 correlate with findings in the current study. Moldable skin barriers provide a customized fit and can be a factor in assisting with prevention and treatment of peristomal skin complications. In a pilot study using moldable barriers,12 5.6% of patients with a new stoma developed peristomal lesions, and peristomal lesions were reduced from 100% to 16.3% in patients who changed from a traditional ostomy system to moldable barrier.10,11

  The present multinational study supports the results of that pilot study. After 2 months using the moldable skin barrier, 4.4% of patients with a new stoma reported peristomal skin lesions, and peristomal skin lesions in patients who changed from a traditional barrier to the study barrier decreased from 100% to 13.8% after 2 months of use.

  The study results also support reduced leakage with use of the moldable skin barriers. From baseline to 2 months, the number of patients who reported leakage as the usual reason for changing the skin barrier decreased from 78.2% to 3.2% in persons with a colostomy, from 88.0% to 8.4% for ileostomy, and from 70.0% to 6.7% in urostomy patients. This is an important finding because leakage is a critical factor in the formation of peristomal lesions and a common source of anxiety.17 Extended wear time has a beneficial impact on costs, indicating that using moldable skin barriers may have a health economic benefit as well.

  Treatment of peristomal skin issues may have additional health care cost benefits. In a modeled cost-effectiveness analysis,4 peristomal skin complications increased the cost of care by 22%. Cost of treatment increased as severity of peristomal skin disorder increased from mild to severe, and cost also increased with level of effluent leakage. The reason for 40% of visits to stoma care nurses was to treat peristomal skin conditions, supporting an impact on cost, as well as on patient quality of life.

  Patient comfort and ease of use regarding an appliance are also necessary for successful rehabilitation after ostomy surgery.18 Patients with an ostomy traditionally wear skin barriers that are precut or need to be cut to fit the stoma opening, requiring teaching and practice. Patients with compromised dexterity may have difficulties completing these tasks. Moldable skin barriers require minimal preparation and enable easy and flexible application. The current study shows high levels of patient satisfaction with moldable skin barriers both from new and experienced persons with a stoma. More than 95% of all patients rated the comfort, ease of preparing, ease of attaching, ease of removing, reliability, and overall evaluation of moldable barrier as excellent or good. At the 2-month follow-up, comfort ratings were also >95% among new and experienced stoma patients. Studies in Canada10 and France12 reported positive results with the use of the study skin barriers. This study has demonstrated effectiveness and patient satisfaction with the use of the moldable barrier worldwide.

  Among patients who switched to using the moldable barrier (Group B), the use of accessory products, especially powder and deodorant/odor control products, also decreased during the 2-month study. The observed reduction in accessory use is encouraging and may provide patient time and cost savings.

Limitations

  This multinational study included 76 sites in 2 European nations and 14 sites in the US. Convenience sampling methods may have biased the sample of patients with existing skin conditions in that caregivers would be more likely to suggest a different system for patients with multiple stoma device concerns. In addition, the study method used did not allow for a direct comparison between the various barriers used. Although patients from several countries participated, not all continents were included in this study.

Conclusion

  A multinational, observational study was conducted to assess the incidence of peristomal lesions, evaluate peristomal skin condition, and assess satisfaction levels with moldable skin barriers among patients with a newly created stoma and patients with an existing stoma experiencing skin complications with traditional barriers. The results of this study demonstrate moldable skin barriers are effective at maintaining and improving peristomal skin integrity. Comfort; ease of preparation, application, and removal; and reliability were scored high by the vast majority of patients. Moldable skin barriers may provide multiple benefits to new and existing patients.

Acknowledgments

  The study was sponsored by ConvaTec. Writing assistance was provided by DZS Clinical Services, Bound Brook, NJ.

  The authors thank all trial investigators. From Germany: Stilla Boyer, Roswitha Dörfer, Regina Friedrich, Elke Fronhoffs-Schommen, Doris Hafermann, Ute Hein, Beate Hoffmann, Jutta Hohloch, Martin Jakob, Katja Jassmann, Marianne Käufler, Elisabeth Kaufhold, Ute Keßler, Alexandra Keuthen, Diana Kowalski, Heike Latuszek, Andreas Lehmann, Alexander Lock, Hans-Jurgen Markus, Markus Scharp, Angelika Schuster, Brunhilde Seefried, Jutta Seib, Katrin Stempfel, Thomas Stermole, Petra Szeitz, Ute Zehren. From Poland: Magdalena Bednarska, Anna Bielska, Agnieszka Biskup, Malgorzata Bocheńska, Barbara Bryczkowska, Katarzyna Cierzniakowska, Hanna Czajkowska, Jolanta Damis, Mariola Dymitrowicz, Agnieszk Dziedzic-Kurzynska, Grazyna Glibowska, Henryka Hrycyna, Katarzyna Jabłonska, Elzbieta Jarema, Anna Jaroszuk, Dorota Jesionka, Ewa Kiełb, Dawid Kilar, Teresa Kresinska, Danuta Kubiak, Jolanta Kuczyk, Bozena Kwasny, Anna Łabunska, Zyta Lajdamik, Beata Ligocka, Mariola Mikołajczak, Ewa Obuszko, Andrzej Piotrowski, Renata Sitek, AnnaŚSmizewska, Urszula Sobczak, Agnieszka Sobkowiak, Magdalena Swojak, Malgorzata Szajter, Boguslawa Walczynska, Elzbieta Waluk, Agata Wasik. From the US: Cindy Barefield, BSN,RN-BC,CWOCN; Carol Bauer, NP; Lisa Brumbaugh; Heather Connell; Janette Dietzler, MSN, RN, CWS, COCN, FACCWS, AAPWCA; Ann Durnal, RN, BSN, CWOCN; Mary Gerlach, MSN, CAN-BC,CWOCN; Sarah Grcich, BSN, BC, CWOCN; Julie Lientz, BSN, RN, WCC, CWON; Cathy Milne, APRN, MSN, BC-ANP/CS, CWOCN; Elizabeth Moore, RN, WCC; Cathy Pauley, RN, BSN, CWOCN; Mary Price, MN, ARNP, CWON; Deborah Saelinger, RN, MS, CWOCN; Thomas Serena, MD; and Denise Taylor, MSN, ET, APRN-BC, CWOCN.

  Dr. Szewczyk is an Associate Professor, Nicolaus Copernicus University; and Ludwik Rydygier Collegium Medicum, Department of Surgery, Clinic of Vascular Surgery and Specialistic Center for the Treatment of Chronic Wounds, University Teaching Hospital of Dr. Jurasz, Bydgoszcz, Poland. Ms. Majewska is an enterostomal therapy nurse, Ostomy Outpatient Clinic, Medical University Teaching Hospital, Bialystok, Poland. Ms. Cabral is a registered family nurse practitioner and a certified wound ostomy continence nurse-advanced practice, Colorectal Surgery, Rhode Island Colorectal Clinic, Pawtucket, RI. Ms. Hölzel-Piontek is a registered pediatric nurse; care expert in ostomy, incontinence, and wound care; and a certified nutritionist, Rehatechnik Jesse, Velbert, Germany. Please address correspondence to: Mary V. Cabral, MS, FNP-BC, CWOCN-AP, Rhode Island Colorectal Clinic, 208 Collyer Street, Suite 301A, Providence, RI 02904; email: marycetn@aol.com.

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