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

NCT ID: NCT02003404

Last Updated: 2016-11-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-02-28

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.

Conditions

Dermatologic Complications

Keywords

ostomy appliance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Control Abdominal Skin

Intervention Type: DEVICE

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

Peristomal Abdominal Skin

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

Peristomal Abdominal Skin

Intervention Type: DEVICE

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

Interventions

Control Abdominal Skin

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

Intervention Type: DEVICE

Peristomal Abdominal Skin

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

Intervention Type: DEVICE

Other Intervention Names

SoftFlex; FlexWear; FlexTend; SoftFlex; FlexWear; FlexTend

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loyola University

OTHER

Sponsor Role: collaborator

Hollister Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Swan, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

La Grange Center for Health

La Grange Park, Illinois, United States

Countries

United States

Other Identifiers

LUHSC IRB #: 205654091813

Identifier Type: OTHER

Identifier Source: secondary_id

5642-O

Identifier Type: -

Identifier Source: org_study_id