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CompletedNCT02003404Updated Nov 11, 2016Results posted

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

An observational study in Dermatologic Complications, sponsored by Hollister Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-11.

Sponsored by Hollister Incorporated · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This purpose of this study is to look at three commercially available ostomy barriers on peristomal (around the stoma) skin. Repeated barrier application and removal over years causes changes to the skin that the investigators wish to investigate. The primary objective is to measure peel force on normal skin and peel force on peristomal skin, with the intent of determining if differences occur. The study hypotheses is that no differences exist.

Read the detailed description

This is a single center, non-invasive exploratory study utilizing a sample of convenience. This study compares three commercially available barrier materials on peristomal skin and normal abdominal skin.

02

Conditions studied

  • Dermatologic Complications

Keywords

  • ostomy appliance
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In context

Lead sponsor

Hollister Incorporated is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Ostomates with a normal peristomal skin and normal ipsilateral abdominal skin

Inclusion criteria

  • Colostomy, Ileostomy, or Urostomy patients at least 6 months post-surgery
  • Males or females, age 18 to 80 years old at the time of enrollment
  • Body Mass Index (BMI) between 18 and 50
  • Willing to have two approximately 5" x 5" areas of the abdomen trimmed with a surgical clipper -- one in a ring around the stoma, and one on the opposite side
  • Willing to remain within the testing room for the duration of the study
  • Willing to allow a third person in the room as a witness for the duration of the study
  • Able to position oneself onto and off of the examining table without the assistance of the Investigator
  • Willing to refrain from vigorous exercise for the duration of the study
  • Willing to not take any anti-inflammatory medications (except for Tylenol/acetaminophen) starting 48 hours prior to the study and for the duration of the study
  • Willing to bring an extra barrier and replace their barrier worn during the study.
  • Willing to follow the protocol as demonstrated by signing the Informed Consent Form
  • In the opinion of the Investigator or qualified site personnel is qualified to participate

Exclusion criteria

Exclusion Criteria:

  • Clinically significant diseases, which may or may not be confined to the testing site, that may contraindicate participation; including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
  • Use of topical drugs on the application site within 1 month.
  • Use of lotions, creams, powders or oils on the application site in the 24 hours prior to application
  • Pregnancy, lactation or planning a pregnancy as determined by interview only
  • Other medical conditions, for example uncontrolled diabetes, which in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk
  • Participation in any clinical test either using the abdomen as a test site or using systemic therapy within the previous thirty days
  • Damaged skin or other skin conditions in or near test sites which includes sunburn, scars, numerous moles or other disfiguration of the test site
  • Significant adipose tissue at the test site that would preclude adequate adhesion of the study devices
  • Known allergy to any of the test materials
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • Control Abdominal Skin

    Apply SoftFlex (standard wear commercial skin barrier), FlexWear (standard wear commercial skin barrier), and FlexTend (extended wear commercial skin barrier), material to non-peristomal abdominal skin.

    Device: Control Abdominal Skin

  • Peristomal Abdominal Skin

    Apply SoftFlex, FlexWear and FlexTend barrier material to peristomal abdominal skin.

    Device: Peristomal Abdominal Skin

Interventions

  • DeviceControl Abdominal Skin

    Three barrier materials will be peeled from abdominal skin after a set period at a set rate.

    Also known as: SoftFlex, FlexWear, FlexTend

  • DevicePeristomal Abdominal Skin

    Three barrier materials will be peeled from abdominal skin after a set period at a set rate.

    Also known as: SoftFlex, FlexWear, FlexTend

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What researchers measure

Primary outcomes

  1. Skin Barrier Peel Force

    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.

    Time frame: 4 hours

07

Results

Posted Oct 19, 2015
Limitations and caveats
Small sample size may not be generalizable to the population.

Participant flow

Participant flow — Overall Study
MilestoneAbdominal Skin Barrier Peel Force
Started17
Completed17
Not completed0

Outcome measures

PrimarySkin Barrier Peel Force

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.

Time frame:
4 hours
Reported as:
Mean · grams
Skin Barrier Peel Force
gramsControl Abdominal Skin Barrier Peel ForcePeristomal Skin Barrier Peel Force
Skin Barrier Peel Force150 ± 10215 ± 15

Adverse events

Collected over 5 months. Period from Sept 1, 2013 to Jan 31, 2014.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Abdominal Skin Barrier Peel Force—0/17 (0%)0/17 (0%)
Peristomal Skin Barrier Peel Force—0/17 (0%)0/17 (0%)

Baseline characteristics

Must have ostomy of any type.

Age, Categorical
Age, Categorical(Participants)Abdominal Skin Barrier Peel Force
<=18 years0
Between 18 and 65 years17
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Abdominal Skin Barrier Peel Force
Female5
Male12
Region of Enrollment
Region of Enrollment(participants)Abdominal Skin Barrier Peel Force
United States17
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Study locations

1 site
  • La Grange Center for Health
    La Grange Park, Illinois 60526, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02003404
Lead sponsor
Hollister Incorporated
Collaborators
Loyola University
Responsible party
Sponsor
First posted
Dec 6, 2013
Start date
Nov 2013
Primary completion
Feb 2014
Completion
Feb 2014
Results posted
Oct 19, 2015
Last update
Nov 11, 2016

Study contacts

James Swan, MD
principal investigator · Loyola University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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