Peristomal Skin Complication
Conditions
Keywords
colostomy, ileostomy, irritant dermatitis, two piece barrier
Brief summary
The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.
Detailed description
This is a single-site, unblinded, historically controlled, first use in humans study of a stoma barrier with a new formulation. Approximately 34 subjects who are currently using a 2-piece tape bordered product and able and willing to wear a product will be enrolled. Each participant is provided with one box containing 20 of the test barriers to be used consecutively according to their normal routine. Each participant is also provided with a box containing 30 pouches selected to most closely resemble their current product. Participants are asked to record the time of application and time of removal of each test barrier and their assessment of relevant characteristics for each test barrier. A clinical evaluation of the peristomal skin is conducted at study entry, at approximately mid way through the study and again at its conclusion. Photographs are taken of the peristomal skin at each visit using a digital camera. Individual participation in terms of wearing the barrier is for 30 days or until the test barrier has been used up, whichever comes first. The study is comprised of 3 visits, an enrolment visit, a mid-study visit and a completion visit and a phone call at approximately day 7.
Interventions
DEVICECASTLE barrier
Prototype barrier to be used in place of current two piece device
Sponsors
Hollister Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age * has colostomy or ileostomy * current uses two piece tape bordered barrier * has mild to moderate peristomal skin irritation * cares for their stoma independently in the community * at least 3 months post-operative * provides informed consent
Exclusion criteria
* has fistula on or near stoma * has been involved in stoma care study in the last 30 days * is pregnant or lactating (determined by interview only) * has existing medical condition that would compromise their participation or follow-up * currently uses convex ostomy products, paste and/or rings * is allergic to test barrier components * is undergoing chemo- or radiotherapy that may affect the interpretation of the results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peristomal Skin Condition | 1 - 30 days | mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Security | 30 days | wear time leakage barrier erosion |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Ileostomy or Colostomy CASTLE Barrier ostomy device
CASTLE barrier: Prototype barrier to be used in place of current two piece device | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Subjects With Ileostomy or Colostomy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United Kingdom | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Peristomal Skin Condition
mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)
Time frame: 1 - 30 days
Population: Study was stopped due to inability to inability to enroll. No data are available for any outcome measures.
Secondary
Security
wear time leakage barrier erosion
Time frame: 30 days
Population: Study was stopped ; no data are available