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

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.

Study Overview

• Status: Completed
• Conditions: Dermatologic Complications
• Intervention / Treatment: Device: Control Abdominal Skin; Device: Peristomal Abdominal Skin

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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ostomates with a normal peristomal skin and normal ipsilateral abdominal skin

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Three barrier materials will be peeled from abdominal skin after a set period at a set rate.; Other Names: SoftFlex; FlexWear; FlexTend
Peristomal Abdominal Skin; Apply SoftFlex, FlexWear and FlexTend barrier material to peristomal abdominal skin.	Device: Peristomal Abdominal Skin; Three barrier materials will be peeled from abdominal skin after a set period at a set rate.; Other Names: SoftFlex; FlexWear; FlexTend

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 hours

Collaborators and Investigators

• Sponsor: Hollister Incorporated
• Collaborators: Loyola University
• Investigators: Principal Investigator: James Swan, MD, Loyola University

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): November 11, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: ostomy appliance
• Other Study ID Numbers: 5642-O; LUHSC IRB #: 205654091813 (Other Identifier: Hollister Incorporated)