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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01526967
First received: February 1, 2012
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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.


Condition
Ostomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™ Skin Barriers

Resource links provided by NLM:


Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Peristomal skin condition [ Time Frame: At day 12 ] [ Designated as safety issue: No ]
    Change in peristomal skin condition from baseline as assessed with the SACS Instrument


Secondary Outcome Measures:
  • Peristomal skin condition [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
    Change in peristomal skin condition from baseline as assessed with the SACS instrument

  • Level of satisfaction [ Time Frame: At 2 months ] [ Designated as safety issue: No ]
    Subjects satisfaction as measured with a satisfaction survey

  • Accessory usage [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
    Subjects use of additional products in stoma care.

  • Peristomal Skin Condition [ Time Frame: At 2 months ] [ Designated as safety issue: No ]
    Change in peristomal skin condition from baseline as assessed with the SACS instrument

  • Level of satisfaction [ Time Frame: At 12 days ] [ Designated as safety issue: No ]
    Subjects level of satisfaction as measured by a satisfaction survey

  • Level of satisfaction [ Time Frame: At 1 month ] [ Designated as safety issue: No ]
    Subjects level of satisfaction as measured with a satisfaction survey


Estimated Enrollment: 2000
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526967

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

No publications provided

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01526967     History of Changes
Other Study ID Numbers: MA-0509-12-U359
Study First Received: February 1, 2012
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ConvaTec Inc.:
ostomy
peristomal skin breakdown
ConvaTec Moldable Skin Barriers

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014