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

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.

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