Clinical trial NCT02003404: Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
Official title: Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatologic Complications
Keywords: ostomy appliance
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Loyola University
First posted: 2013-12-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ostomates with a normal peristomal skin and normal ipsilateral abdominal skin

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin Barrier Peel Force
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: La Grange Park
country: United States
facility: La Grange Center for Health
state: Illinois
Study officials:
affiliation: Loyola University
name: James Swan, MD
role: PRINCIPAL_INVESTIGATOR
References: