A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

Phase 4-A Clinical Comparison of a Marketed Moldable Skin Barrier Versus a Marketed Stretch-to-Fit Skin Barrier in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Peristomal Skin Complication
• Intervention / Treatment: Device: Sur-Fit Natura; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85742
      • Independent Nurse Consultants LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Hollister FormaFlex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to maintain secure (snug) fit around stoma	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	Two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Independent Nurse Consultants LLC
• Collaborators: ConvaTec Inc.
• Investigators: Principal Investigator: Ann M Durnal, RN BSN WOCN, Independent Nurse Consultants LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Estimate): September 24, 2013
• Last Update Submitted That Met QC Criteria: September 23, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: INC#001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No