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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ostomy

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85742
      • Independent Nurse Consultant
  • California
    • Concord, California, United States, 94520
      • John Muir Health Concord Campus
  • Connecticut
    • Plymoth, Connecticut, United States, 06782
      • Conn. Clinical Nursing Associate, LLC
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Home Health
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Porter Hospital
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02140
      • Serena Group - Dr. Thomas Serena MD
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Henry Ford Macomb Hospital
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Center
  • Missouri
    • St. Louis, Missouri, United States, 63128
      • St. Anthony's Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43222
      • ID Med Inc.
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • RI Colorectal Clinic, LLC
  • Texas
    • Baytown, Texas, United States, 77521
      • San Jacinto Methodist Hospital
  • Washington
    • Renton, Washington, United States, 98055
      • NW Pavillion Ostomy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peristomal skin condition	Change in peristomal skin condition from baseline as assessed with the SACS Instrument	At day 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Study Chair: Qing Li, Ph.D, MD, ConvaTec Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 14, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: ostomy; peristomal skin breakdown; ConvaTec Moldable Skin Barriers
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: MA-0509-12-U359