A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

Peristomal Skin Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534039
• Other study ID #: INC#001
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2011
• Last updated: September 23, 2013
• Start date: December 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2013
• Source: Independent Nurse Consultants LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Peristomal Skin Complication

Intervention

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

Locations

Country	Name	City	State
United States	Independent Nurse Consultants LLC	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Independent Nurse Consultants LLC	ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Skin Protection	SACS assessment by patient at each barrier change up to 2 weeks; SACS assessment by nurse at 2 weeks	Two weeks	No
Secondary	Wear Time	1. Time of barrier change recorded	Two weeks	No
Secondary	Ease of use	1. Assessment by subject response to questionnaire	Two weeks	No
Secondary	Ease of teaching	1. Assessment by nurse of ability to teach subject to use barrier	Two weeks	No
Secondary	Comfort	1. Subject assessment of comfort of barrier at each change	Two weeks	No