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OpenTrials
Completed

NCT Number: NCT01534039

A Clinical Comparison of Two Marketed Skin Barriers on 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.

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Key information

Conditions

Peristomal Skin Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Independent Nurse Consultants LLC

Tucson, Arizona, 85742, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sur-Fit Natura

Device

ConvaTec Moldable Skin Barrier for ostomy patients

Other names: ConvaTec Moldable Skin Barrier

FormaFlex

Device

Hollister skin barrier for ostomy patients

Other names: Hollister FormaFlex

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Wear Time

    Time frame: Two weeks

    • Time of barrier change recorded

  3. Ease of use

    Time frame: Two weeks

    • Assessment by subject response to questionnaire

  4. Ease of teaching

    Time frame: Two weeks

    • Assessment by nurse of ability to teach subject to use barrier

  5. Comfort

    Time frame: Two weeks

    • Subject assessment of comfort of barrier at each change

Sponsors and collaborators

Lead sponsor

Independent Nurse Consultants LLC

Other

Collaborators

  • ConvaTec Inc.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 16, 2012
Registry last updated
Sep 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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