Trial Outcomes & Findings for Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin (NCT NCT02003404)

Results Overview

Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.

Recruitment status

COMPLETED

Target enrollment

17 participants

Primary outcome timeframe

4 hours

Results posted on

2016-11-11

Participant Flow

All 17 participants wore all three barrier types on control area AND peristomal area NOT 34 participants in study only 17 participants in study.

Participant milestones

Participant milestones
Measure	Abdominal Skin Barrier Peel Force Barrier materials were attached and peeled off control and peristomal abdominal skin. Three commercial barrier materials (SoftFlex, FlexWear and FlexTend) were peeled from control or peristomal abdominal skin after a set period at a set rate.
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abdominal Skin Barrier Peel Force n=17 Participants Three commerical barrier materials, SoftFlex, FlexWear and FlexTend barrier were peeled from control or peristomal abdominal skin after a set period at a set rate.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.

Outcome measures

Outcome measures
Measure	Control Abdominal Skin Barrier Peel Force n=17 Participants Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.	Peristomal Skin Barrier Peel Force n=17 Participants Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
Skin Barrier Peel Force	150 grams Standard Deviation 10	215 grams Standard Deviation 15

Adverse Events

Control Abdominal Skin Barrier Peel Force

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peristomal Skin Barrier Peel Force

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr James Swan, MD

Loyola University of Chicago

Phone: 708-485-1271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place