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

Convatec

Status: Unknown

Conditions: Colostomy; Urostomy; Ileostomy

Treatments: Device: Natura Accordion with ConvaTec Moldable Technology; Device: Esteem Plus with ConvaTec Moldable Technology; Device: Esteem synergy Plus with ConvaTec Moldable Technology; Device: Natura with ConvaTec Moldable Technology

Study type: Observational

Funder types: Industry

Identifiers

NCT02499588

CC-0509-15-U375

Details and patient eligibility

About

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.

Enrollment: 600 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 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).

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.