NCT01534039

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

5 months

First QC Date

December 19, 2011

Last Update Submit

September 23, 2013

Conditions

Peristomal Skin Complication

Outcome Measures

Primary Outcomes (1)

  • Ability to maintain secure (snug) fit around stoma

    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

    Two weeks

Secondary Outcomes (5)

  • Skin Protection

    Two weeks

  • Wear Time

    Two weeks

  • Ease of use

    Two weeks

  • Ease of teaching

    Two weeks

  • Comfort

    Two weeks

Study Arms (2)

Sur-Fit Natura/FormaFlex

ACTIVE COMPARATOR

Subject will be on Surfit Moldable for 2 weeks then crossover to Formaflex

Device: Sur-Fit Natura

FormaFlex/Sur-Fit Natura

ACTIVE COMPARATOR

Subject will be on Formaflex for 2 weeks then crossover to Surfit Moldable

Device: FormaFlex

Interventions

Sur-Fit NaturaDEVICE

ConvaTec Moldable Skin Barrier for ostomy patients

Also known as: ConvaTec Moldable Skin Barrier
Sur-Fit Natura/FormaFlex
FormaFlexDEVICE

Hollister skin barrier for ostomy patients

Also known as: Hollister FormaFlex
FormaFlex/Sur-Fit Natura

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Needing convexity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Independent Nurse Consultants LLC

Tucson, Arizona, 85742, United States

Location

Study Officials

  • Ann M Durnal, RN BSN WOCN

    Independent Nurse Consultants LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2011

First Posted

February 16, 2012

Study Start

December 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

US(1)