A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01534039
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : September 24, 2013
ConvaTec Inc.
Information provided by (Responsible Party):
Independent Nurse Consultants LLC

Brief Summary:

A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or urostomy.

Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin protection, wear-time, ease of use, ease of teaching, and comfort.

Condition or disease Intervention/treatment Phase
Peristomal Skin Complication Device: Sur-Fit Natura Device: FormaFlex Phase 4

Detailed Description:
Study to include 60 subjects, three centers, total of 4 weeks, 2 weeks in each product. Subjects recruited from a population of persons who have had an existing fecal or urinary stoma for a duration of at least three months. There is no restriction on primary diagnosis for ostomy surgery. Subjects must be of legal consenting age, must currently be managing their own stoma with a two piece pouching system, either a pre-cut, cut to fit, moldable or stretch-to-fit, any manufacturer. Subjects may not require convexity and be willing to not to use any accessory products during the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Phase 4-A Clinical Comparison of a Marketed Moldable Skin Barrier Versus a Marketed Stretch-to-Fit Skin Barrier in Healthy Volunteers
Study Start Date : December 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Active Comparator: Sur-Fit Natura/FormaFlex
Subject will be on Surfit Moldable for 2 weeks then crossover to Formaflex
Device: Sur-Fit Natura
ConvaTec Moldable Skin Barrier for ostomy patients
Other Name: ConvaTec Moldable Skin Barrier

Active Comparator: FormaFlex/Sur-Fit Natura
Subject will be on Formaflex for 2 weeks then crossover to Surfit Moldable
Device: FormaFlex
Hollister skin barrier for ostomy patients
Other Name: Hollister FormaFlex

Primary Outcome Measures :
  1. Ability to maintain secure (snug) fit around stoma [ Time Frame: Two weeks ]
    1. Subject assessment of barrier fit based on questionnaire at each skin barrier change up to 2 weeks
    2. Barrier gap assessment performed by nurse at 2 weeks
    3. Barrier gap assessment performed by subject at each skin barrier change up to 2 weeks

Secondary Outcome Measures :
  1. Skin Protection [ Time Frame: Two weeks ]
    1. SACS assessment by patient at each barrier change up to 2 weeks
    2. SACS assessment by nurse at 2 weeks

  2. Wear Time [ Time Frame: Two weeks ]
    1. Time of barrier change recorded

  3. Ease of use [ Time Frame: Two weeks ]
    1. Assessment by subject response to questionnaire

  4. Ease of teaching [ Time Frame: Two weeks ]
    1. Assessment by nurse of ability to teach subject to use barrier

  5. Comfort [ Time Frame: Two weeks ]
    1. Subject assessment of comfort of barrier at each change

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Existing fecal or urinary ostomy for at least three months,consenting age, able to perform independent ostomy care, willing to not use accessory products, currently wearing a 2 piece marketed product.
  • Able to participate for four weeks.

Exclusion Criteria:

  • Needing convexity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01534039

United States, Arizona
Independent Nurse Consultants LLC
Tucson, Arizona, United States, 85742
Sponsors and Collaborators
Independent Nurse Consultants LLC
ConvaTec Inc.
Principal Investigator: Ann M Durnal, RN BSN WOCN Independent Nurse Consultants LLC

Responsible Party: Independent Nurse Consultants LLC Identifier: NCT01534039     History of Changes
Other Study ID Numbers: INC#001
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013