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


N/A
18 Years
N/A
Open (Enrolling)
Both
Ostomy

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Peristomal skin condition

Outcome Description:

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

Outcome Time Frame:

At day 12

Safety Issue:

No

Principal Investigator

Qing Li, Ph.D, MD

Investigator Role:

Study Chair

Investigator Affiliation:

ConvaTec Inc.

Authority:

United States: Institutional Review Board

Study ID:

MA-0509-12-U359

NCT ID:

NCT01526967

Start Date:

January 2012

Completion Date:

December 2012

Related Keywords:

  • Ostomy
  • ostomy
  • peristomal skin breakdown
  • ConvaTec Moldable Skin Barriers
  • Skin Diseases

Name

Location

Henry Ford Macomb HospitalClinton Township, Michigan  48038
Karmanos Cancer CenterDetroit, Michigan  48201
Independent Nurse ConsultantTucson, Arizona  85742
John Muir Health Concord CampusConcord, California  94520
Conn. Clinical Nursing Associate, LLCPlymoth, Connecticut  06782
Baptist Home HealthJacksonville, Florida  32207
Porter HospitalValparaiso, Indiana  46383
Serena Group - Dr. Thomas Serena MDCambridge, Massachusetts  02140
St. Anthony's Medical CenterSt. Louis, Missouri  63128
ID Med Inc.Columbus, Ohio  43222
RI Colorectal Clinic, LLCPawtucket, Rhode Island  02860
San Jacinto Methodist HospitalBaytown, Texas  77521
NW Pavillion Ostomy ClinicRenton, Washington  98055