A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

Overview

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.

Full Title of Study: “Phase 4-A Clinical Comparison of a Marketed Moldable Skin Barrier Versus a Marketed Stretch-to-Fit Skin Barrier in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2012

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.

Interventions

  • Device: Sur-Fit Natura
    • ConvaTec Moldable Skin Barrier for ostomy patients
  • Device: FormaFlex
    • Hollister skin barrier for ostomy patients

Arms, Groups and Cohorts

  • Active Comparator: Sur-Fit Natura/FormaFlex
    • Subject will be on Surfit Moldable for 2 weeks then crossover to Formaflex
  • Active Comparator: FormaFlex/Sur-Fit Natura
    • Subject will be on Formaflex for 2 weeks then crossover to Surfit Moldable

Clinical Trial Outcome Measures

Primary Measures

  • Ability to maintain secure (snug) fit around stoma
    • Time Frame: Two weeks
    • Subject assessment of barrier fit based on questionnaire at each skin barrier change up to 2 weeks Barrier gap assessment performed by nurse at 2 weeks Barrier gap assessment performed by subject at each skin barrier change up to 2 weeks

Secondary Measures

  • Skin Protection
    • Time Frame: Two weeks
    • SACS assessment by patient at each barrier change up to 2 weeks SACS assessment by nurse at 2 weeks
  • Wear Time
    • Time Frame: Two weeks
    • 1. Time of barrier change recorded
  • Ease of use
    • Time Frame: Two weeks
    • 1. Assessment by subject response to questionnaire
  • Ease of teaching
    • Time Frame: Two weeks
    • 1. Assessment by nurse of ability to teach subject to use barrier
  • Comfort
    • Time Frame: Two weeks
    • 1. Subject assessment of comfort of barrier at each change

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Independent Nurse Consultants LLC
  • Collaborator
    • ConvaTec Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ann M Durnal, RN BSN WOCN, Principal Investigator, Independent Nurse Consultants LLC

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