User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™

• Conditions: Colostomy; Urostomy; Ileostomy

• Registration Number: NCT02499588
• Lead Sponsor: ConvaTec Inc.

Brief Summary

The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care following surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-07
• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-16
• Last Update Posted: 2015-07-16
• Primary Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 ConvaTec Moldable Technology™ per package insert, within the context of routine clinical care is used as the first long-term (within 7 days of ostomy surgery) system following surgery and who have intact peristomal skin (healthy or SACs L1).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peri-stomal skin condition at 8-15 days following the application of the barrier.	8-15 days	Using SACs scale to determine incidence and severity of lesions

Secondary Outcome Measures

Name	Time	Method
Peristomal skin condition in ostomates at 1 month (± 15 days) following the application of the barrier.	1 month (± 15 days)	Using SACs scale to determine incidence and severity of lesions
Peristomal skin condition in ostomates at 2 months (± 15 days) following the application of the barrier.	2 months (± 15 days)	Using SACs scale to determine incidence and severity of lesions

Trial Locations

Locations (1)

Voivodeship Specialistic Hospital in Gorzow Wlkp.; 🇵🇱 Gorzow Wielkopolski, Lubuskie, Poland