Observational Evaluation of the Peristomal Skin Condition in Ostomates

NCT01526967 | Unknown

• 1 other identifier: MA-0509-12-U359
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 13

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.

Conditions

Ostomy

Keywords

ostomy; peristomal skin breakdown; ConvaTec Moldable Skin Barriers

Outcome Measures

Primary Outcomes (1)

• Peristomal skin condition

  Change in peristomal skin condition from baseline as assessed with the SACS Instrument

  At day 12

Secondary Outcomes (6)

• Peristomal skin condition

  at 1 month

• Level of satisfaction

  At 2 months

• Accessory usage

  Up to 2 months

• Peristomal Skin Condition

  At 2 months

• Level of satisfaction

  At 12 days

Study Arms (2)

New moldable user

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

colostomates, ileostomates, urostomates in acute care settings or community at large.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (13)

Independent Nurse Consultant

Tucson, Arizona, 85742, United States

Location

John Muir Health Concord Campus

Concord, California, 94520, United States

Location

Conn. Clinical Nursing Associate, LLC

Plymoth, Connecticut, 06782, United States

Location

Baptist Home Health

Jacksonville, Florida, 32207, United States

Location

Porter Hospital

Valparaiso, Indiana, 46383, United States

Location

Serena Group - Dr. Thomas Serena MD

Cambridge, Massachusetts, 02140, United States

Location

Henry Ford Macomb Hospital

Clinton Township, Michigan, 48038, United States

Location

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

St. Anthony's Medical Center

St Louis, Missouri, 63128, United States

Location

ID Med Inc.

Columbus, Ohio, 43222, United States

Location

RI Colorectal Clinic, LLC

Pawtucket, Rhode Island, 02860, United States

Location

San Jacinto Methodist Hospital

Baytown, Texas, 77521, United States

Location

NW Pavillion Ostomy Clinic

Renton, Washington, 98055, United States

Location

Study Officials

• Qing Li, Ph.D, MD

  ConvaTec Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 6, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (13)