Peristomal Skin ComplicationNCT01530087
Preliminary Evaluation of CASTLE Barrier Prototype UK
A study testing CASTLE barrier in people with Peristomal Skin Complication, run by Hollister Incorporated at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peristomal Skin Complication
- What is being tested?
- CASTLE barrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas
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.
Read the 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.
- Conditions
- Peristomal Skin Complication
- Being tested
- CASTLE barrier
- Keywords
- colostomy, ileostomy, irritant dermatitis, two piece barrier
- Medical subject headings
- Dermatitis, Irritant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASTLE barrierDevice
Prototype barrier to be used in place of current two piece device
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | CASTLE Barrier Receives: Device: CASTLE barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peristomal Skin Condition
mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)
Measured: 1 - 30 days
Secondary outcomes (1)
Security
wear time leakage barrier erosion
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionAug 2012
Why it stopped: Inability of site to recruit/enroll target population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peristomal Skin ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Murahata, PhD, Study director, Hollister Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530087
- Sponsor's protocol ID
- 4518-O
- Other IDs
- CIV-GB-11-07-001241
- Status last verified
- Sep 2015
- First submitted
- 7 Feb 2012
- Last updated
- 22 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas
- ClinicalTrials.gov ID
- NCT01530087
- Acronym / sponsor ID
- 4518-O
- Conditions
- Peristomal Skin Complication
- Keywords
- colostomy, ileostomy, irritant dermatitis, two piece barrier
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability of site to recruit/enroll target population
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Posted 22 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: CASTLE barrierCASTLE Barrier |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASTLE barrierPrototype barrier to be used in place of current two piece device | Device | Treatment |
Primary outcome
Peristomal Skin Condition
Time frame: 1 - 30 days
mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)
1 secondary outcome
Security
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Peristomal Skin Complication
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Murahata, PhD study director
Hollister Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CASTLE barrier in people with Peristomal Skin Complication, run by Hollister Incorporated at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peristomal Skin Condition (time frame: 1 - 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.