Overview

This trial is active, not recruiting.

Condition ostomy
Sponsor ConvaTec Inc.
Start date January 2012
End date December 2012
Trial size 2000 participants
Trial identifier NCT01526967, MA-0509-12-U359

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects presenting with peristomal lesions with a traditional barrier and for whom a ConvaTec Moldable Technology™ Skin Barrier is used as a replacement.
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.

Primary Outcomes

Measure
Peristomal skin condition
time frame: At day 12

Secondary Outcomes

Measure
Peristomal skin condition
time frame: at 1 month
Level of satisfaction
time frame: At 2 months
Accessory usage
time frame: Up to 2 months
Peristomal Skin Condition
time frame: At 2 months
Level of satisfaction
time frame: At 12 days
Level of satisfaction
time frame: At 1 month

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Observational Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™ Skin Barriers
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by ConvaTec Inc..