Dermatologic Complications
Conditions
Keywords
ostomy appliance
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.
Interventions
DEVICEControl Abdominal Skin
Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
DEVICEPeristomal Abdominal Skin
Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
Sponsors
Loyola University
Hollister Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Barrier Peel Force | 4 hours | 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. |
Countries
United States
Participant flow
Pre-assignment details
All 17 participants wore all three barrier types on control area AND peristomal area NOT 34 participants in study only 17 participants in study.
Participants by arm
| Arm | Count |
|---|---|
| Abdominal Skin Barrier Peel Force Three commerical barrier materials, SoftFlex, FlexWear and FlexTend barrier were peeled from control or peristomal abdominal skin after a set period at a set rate. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Abdominal Skin Barrier Peel Force |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Abdominal Skin Barrier Peel Force | Skin Barrier Peel Force | 150 grams | Standard Deviation 10 |
| Peristomal Skin Barrier Peel Force | Skin Barrier Peel Force | 215 grams | Standard Deviation 15 |