Peristomal Skin ComplicationNCT01413672
Preliminary Evaluation of CASTLE Barrier North American Prototype
An observational study of Peristomal Skin Complication, run by Hollister Incorporated at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation. 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?
- Use of CASTLE barrier
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: subjects currently known to investigators
Who may be able to join
- at least 18 years of age has colostomy or ileostomy current user of two-piece, flat, tape bordered barrier mild to moderate skin peristomal skin irritation community dwelling and cares for stoma independently at least 3 months post-operative provides informed consent
Who cannot join
- presence of fistula on or near stoma prior participation in stoma care study within past 30 days pregnant or lactating (interview only) uses convex product, paste and/or rings known allergy to test barrier composition existing medical condition or therapy that might affect ability to participate or interpretation of study results
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
St. Louis Medical
Fenton, Missouri, 63026
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
ET Nursing Services
Jacksonville, Florida, 32246
Restored Images
Kansas City, Missouri, 64119
Canada1 site
Ostomy Care & Supply Centre
New Westminster, British Columbia, V3M 2T5
About this study
Official title: Peristomal Skin Irritation: A Preliminary Evaluation of CASTLE Barrier North American Prototype
The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation.
- Conditions
- Peristomal Skin Complication
- Being tested
- Use of CASTLE barrier
- Keywords
- ostomy, colostomy, ileostomy, barrier, irritation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of CASTLE barrierDevice
Test barrier to be used in place of normal barrier. Otherwise normal routine is followed
| Study group | Role | What they receive |
|---|---|---|
| person with ostomy | Community dwelling subject with either colostomy or ileostomy and at least 3 months post-surgery. Receives: Device: Use of CASTLE barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peristomal skin irritation
Measured: 30 days
Secondary outcomes (1)
Security
wear time, lifting of barrier from skin, leakage
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 posted10 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Murahata, Ph.D., Study director, Hollister Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413672
- Sponsor's protocol ID
- 5075-O
- Status last verified
- Dec 2011
- First submitted
- 6 Aug 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peristomal Skin Irritation: A Preliminary Evaluation of CASTLE Barrier North American Prototype
- ClinicalTrials.gov ID
- NCT01413672
- Acronym / sponsor ID
- 5075-O
- Conditions
- Peristomal Skin Complication
- Keywords
- ostomy, colostomy, ileostomy, barrier, irritation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
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 determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| person with ostomy | – | Device: Use of CASTLE barrierCommunity dwelling subject with either colostomy or ileostomy and at least 3 months post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects currently known to investigators
Key inclusion criteria (1 listed)
- at least 18 years of age has colostomy or ileostomy current user of two-piece, flat, tape bordered barrier mild to moderate skin peristomal skin irritation community dwelling and cares for stoma independently at least 3 months post-operative provides informed consent
Key exclusion criteria (1 listed)
- presence of fistula on or near stoma prior participation in stoma care study within past 30 days pregnant or lactating (interview only) uses convex product, paste and/or rings known allergy to test barrier composition existing medical condition or therapy that might affect ability to participate or interpretation of study results
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 |
|---|---|---|
| Use of CASTLE barrierTest barrier to be used in place of normal barrier. Otherwise normal routine is followed | Device | person with ostomy |
Primary outcome
Peristomal skin irritation
Time frame: 30 days
1 secondary outcome
Security
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
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, Ph.D. study director
Hollister Incorporated
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peristomal Skin Complication, run by Hollister Incorporated at 5 sites in 2 countries.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 irritation (time frame: 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 12 Dec 2011.