Observational Evaluation of the Peristomal Skin Condition in Ostomates

Ostomy Clinical Trial

— OSMOSE  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01526967
• Other study ID #: MA-0509-12-U359
• Status: Unknown status
• Phase: N/A
• First received: February 1, 2012
• Last updated: December 14, 2012
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 2000
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ostomy
• Skin Diseases

Locations

Country	Name	City	State
United States	San Jacinto Methodist Hospital	Baytown	Texas
United States	Serena Group - Dr. Thomas Serena MD	Cambridge	Massachusetts
United States	Henry Ford Macomb Hospital	Clinton Township	Michigan
United States	ID Med Inc.	Columbus	Ohio
United States	John Muir Health Concord Campus	Concord	California
United States	Karmanos Cancer Center	Detroit	Michigan
United States	Baptist Home Health	Jacksonville	Florida
United States	RI Colorectal Clinic, LLC	Pawtucket	Rhode Island
United States	Conn. Clinical Nursing Associate, LLC	Plymoth	Connecticut
United States	NW Pavillion Ostomy Clinic	Renton	Washington
United States	St. Anthony's Medical Center	St. Louis	Missouri
United States	Independent Nurse Consultant	Tucson	Arizona
United States	Porter Hospital	Valparaiso	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peristomal skin condition	Change in peristomal skin condition from baseline as assessed with the SACS Instrument	At day 12
Secondary	Peristomal skin condition	Change in peristomal skin condition from baseline as assessed with the SACS instrument	at 1 month
Secondary	Level of satisfaction	Subjects satisfaction as measured with a satisfaction survey	At 2 months
Secondary	Accessory usage	Subjects use of additional products in stoma care.	Up to 2 months
Secondary	Peristomal Skin Condition	Change in peristomal skin condition from baseline as assessed with the SACS instrument	At 2 months
Secondary	Level of satisfaction	Subjects level of satisfaction as measured by a satisfaction survey	At 12 days
Secondary	Level of satisfaction	Subjects level of satisfaction as measured with a satisfaction survey	At 1 month