Observational Evaluation of the Peristomal Skin Condition in Ostomates

• Conditions: Ostomy

• Registration Number: NCT01526967
• Lead Sponsor: ConvaTec Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-06
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

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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
Peristomal skin condition	At day 12	Change in peristomal skin condition from baseline as assessed with the SACS Instrument

Secondary Outcome Measures

Name	Time	Method
Peristomal Skin Condition	At 2 months	Change in peristomal skin condition from baseline as assessed with the SACS instrument
Peristomal skin condition	at 1 month	Change in peristomal skin condition from baseline as assessed with the SACS instrument
Level of satisfaction	At 1 month	Subjects level of satisfaction as measured with a satisfaction survey
Accessory usage	Up to 2 months	Subjects use of additional products in stoma care.

Trial Locations

Locations (13)

ID Med Inc.; 🇺🇸 Columbus, Ohio, United States

Independent Nurse Consultant; 🇺🇸 Tucson, Arizona, United States

Conn. Clinical Nursing Associate, LLC; 🇺🇸 Plymoth, Connecticut, United States

John Muir Health Concord Campus; 🇺🇸 Concord, California, United States

Baptist Home Health; 🇺🇸 Jacksonville, Florida, United States

Porter Hospital; 🇺🇸 Valparaiso, Indiana, United States

Serena Group - Dr. Thomas Serena MD; 🇺🇸 Cambridge, Massachusetts, United States

Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States

St. Anthony's Medical Center; 🇺🇸 St. Louis, Missouri, United States

RI Colorectal Clinic, LLC; 🇺🇸 Pawtucket, Rhode Island, United States

NW Pavillion Ostomy Clinic; 🇺🇸 Renton, Washington, United States

San Jacinto Methodist Hospital; 🇺🇸 Baytown, Texas, United States

Henry Ford Macomb Hospital; 🇺🇸 Clinton Township, Michigan, United States