Dermatologic ComplicationsNCT02003404
Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
An observational study of Dermatologic Complications, run by Hollister Incorporated at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatologic Complications
- What is being tested?
- Peristomal Abdominal Skin
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2014
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ostomates with a normal peristomal skin and normal ipsilateral abdominal skin
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
La Grange Center for Health
La Grange Park, Illinois, 60526
About this study
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.
Read the 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.
- Conditions
- Dermatologic Complications
- Being tested
- Control Abdominal Skin, Peristomal Abdominal Skin
- Keywords
- ostomy appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Abdominal SkinDevice
Also called SoftFlex, FlexWear, FlexTend
Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
Peristomal Abdominal SkinDevice
Also called SoftFlex, FlexWear, FlexTend
Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
| Study group | Role | What they receive |
|---|---|---|
| Control Abdominal Skin | Apply SoftFlex (standard wear commercial skin barrier), FlexWear (standard wear commercial skin barrier), and FlexTend (extended wear commercial skin barrier), material to non-peristomal abdominal skin. Receives: Device: Control Abdominal Skin | |
| Peristomal Abdominal Skin | Apply SoftFlex, FlexWear and FlexTend barrier material to peristomal abdominal skin. Receives: Device: Peristomal Abdominal Skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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 Dermatologic ComplicationsStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Loyola University
- Responsible party
- Sponsor
- Investigators
- James Swan, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003404
- Sponsor's protocol ID
- 5642-O
- Other IDs
- LUHSC IRB #: 205654091813
- Status last verified
- Oct 2016
- First submitted
- 20 Nov 2013
- Last updated
- 11 Nov 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 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
- ClinicalTrials.gov ID
- NCT02003404
- Acronym / sponsor ID
- 5642-O
- Conditions
- Dermatologic Complications
- Keywords
- ostomy appliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Loyola University
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Posted 19 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Abdominal Skin | – | Device: Control Abdominal SkinApply SoftFlex (standard wear commercial skin barrier), FlexWear (standard wear commercial skin barrier), and FlexTend (extended wear commercial skin barrier), material to non-peristomal abdominal skin. |
| Peristomal Abdominal Skin | – | Device: Peristomal Abdominal SkinApply SoftFlex, FlexWear and FlexTend barrier material to peristomal abdominal skin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ostomates with a normal peristomal skin and normal ipsilateral abdominal skin
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Control Abdominal SkinAlso: SoftFlex, FlexWear, FlexTendThree barrier materials will be peeled from abdominal skin after a set period at a set rate. | Device | Control Abdominal Skin |
| Peristomal Abdominal SkinAlso: SoftFlex, FlexWear, FlexTendThree barrier materials will be peeled from abdominal skin after a set period at a set rate. | Device | Peristomal Abdominal Skin |
Primary outcome
Skin Barrier Peel Force
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James Swan, MD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatologic Complications, run by Hollister Incorporated at 1 site in United States.
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 12 inclusion and 9 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 11 Nov 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 States. 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 19 Oct 2015). 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?
Skin Barrier Peel Force (time frame: 4 hours). 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 11 Nov 2016.