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

Dermatologic Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003404
• Other study ID #: 5642-O
• Secondary ID: LUHSC IRB #: 205
• Status: Completed
• Phase: N/A
• First received: November 20, 2013
• Last updated: September 22, 2015
• Start date: November 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2015
• Source: Hollister Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatologic Complications

Intervention

Device:
• Control Abdominal Skin
Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
• Peristomal Abdominal Skin
Three barrier materials will be peeled from abdominal skin after a set period at a set rate.

Locations

Country	Name	City	State
United States	La Grange Center for Health	La Grange Park	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Hollister Incorporated	Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No