Observational Evaluation of the Peristomal Skin Condition in Ostomates

Study Overview
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Brief Summary
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The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.

Official Title
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Observational Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™ Skin Barriers

Conditions
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Ostomy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are 18 years old and older. Subjects who agree to participate in the evaluation and who have signed the informed consent form. Subjects presenting with a stoma (ileostomy, colostomy or urostomy). Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin. OR Subjects presenting with peristomal skin lesions using a traditional barrier and for whom a decision to replace the traditional barrier with ConvaTec Moldable Technology™ Skin Barrier per package insert is made in the context of routine clinical care. Exclusion Criteria: Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem. Subjects who are in a simultaneous clinical evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New moldable user<br>Subjects presenting with peristomal lesions with a traditional barrier and for whom a ConvaTec Moldable Technology™ Skin Barrier is used as a replacement. | |
| New osomate<br>Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peristomal skin condition | Change in peristomal skin condition from baseline as assessed with the SACS Instrument | At day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peristomal skin condition | Change in peristomal skin condition from baseline as assessed with the SACS instrument | at 1 month | 
| Level of satisfaction | Subjects satisfaction as measured with a satisfaction survey | At 2 months | 
| Accessory usage | Subjects use of additional products in stoma care. | Up to 2 months | 
| Peristomal Skin Condition | Change in peristomal skin condition from baseline as assessed with the SACS instrument | At 2 months | 
| Level of satisfaction | Subjects level of satisfaction as measured by a satisfaction survey | At 12 days | 
| Level of satisfaction | Subjects level of satisfaction as measured with a satisfaction survey | At 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ostomy, peristomal skin breakdown, ConvaTec Moldable Skin Barriers