A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
ConvaTec Inc.
Information provided by (Responsible Party):
Independent Nurse Consultants LLC
ClinicalTrials.gov Identifier:
NCT01534039
First received: December 19, 2011
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Peristomal Skin Complication
Device: Sur-Fit Natura
Device: FormaFlex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Independent Nurse Consultants LLC:

Primary Outcome Measures:
  • Ability to maintain secure (snug) fit around stoma [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    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:
  • Skin Protection [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    1. SACS assessment by patient at each barrier change up to 2 weeks
    2. SACS assessment by nurse at 2 weeks

  • Wear Time [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    1. Time of barrier change recorded

  • Ease of use [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    1. Assessment by subject response to questionnaire

  • Ease of teaching [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    1. Assessment by nurse of ability to teach subject to use barrier

  • Comfort [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    1. Subject assessment of comfort of barrier at each change


Enrollment: 60
Study Start Date: December 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01534039

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

No publications provided

Responsible Party: Independent Nurse Consultants LLC
ClinicalTrials.gov Identifier: NCT01534039     History of Changes
Other Study ID Numbers: INC#001
Study First Received: December 19, 2011
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014