Observational Evaluation of the Peristomal Skin Condition in Ostomates (OSMOSE)

Convatec

Status: Unknown

Conditions: Ostomy

Study type: Observational

Funder types: Industry

Identifiers

NCT01526967

MA-0509-12-U359

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

New moldable user

Description:

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

Description:

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.