Peristomal Skin ComplicationPhase 4NCT01534039
A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers
A Phase 4 study testing Sur-Fit Natura and FormaFlex in people with Peristomal Skin Complication, run by Independent Nurse Consultants LLC at 1 site in United States.
Trial summary
A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or urostomy. Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin protection, wear-time, ease of use, ease of teaching, and comfort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peristomal Skin Complication
- What is being tested?
- Sur-Fit Natura and FormaFlex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to May 2012
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Existing fecal or urinary ostomy for at least three months,consenting age, able to perform independent ostomy care, willing to not use accessory products, currently wearing a 2 piece marketed product.
- Able to participate for four weeks.
Who cannot join
- Needing convexity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Independent Nurse Consultants LLC
Tucson, Arizona, 85742
About this study
Official title: Phase 4-A Clinical Comparison of a Marketed Moldable Skin Barrier Versus a Marketed Stretch-to-Fit Skin Barrier in Healthy Volunteers
A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or urostomy.
Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin protection, wear-time, ease of use, ease of teaching, and comfort.
Read the detailed description
Study to include 60 subjects, three centers, total of 4 weeks, 2 weeks in each product. Subjects recruited from a population of persons who have had an existing fecal or urinary stoma for a duration of at least three months. There is no restriction on primary diagnosis for ostomy surgery. Subjects must be of legal consenting age, must currently be managing their own stoma with a two piece pouching system, either a pre-cut, cut to fit, moldable or stretch-to-fit, any manufacturer. Subjects may not require convexity and be willing to not to use any accessory products during the study.
- Conditions
- Peristomal Skin Complication
- Being tested
- Sur-Fit Natura, FormaFlex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sur-Fit NaturaDevice
Also called ConvaTec Moldable Skin Barrier
ConvaTec Moldable Skin Barrier for ostomy patients
FormaFlexDevice
Also called Hollister FormaFlex
Hollister skin barrier for ostomy patients
| Study group | Role | What they receive |
|---|---|---|
| Sur-Fit Natura/FormaFlex | Active comparator | Subject will be on Surfit Moldable for 2 weeks then crossover to Formaflex Receives: Device: Sur-Fit Natura |
| FormaFlex/Sur-Fit Natura | Active comparator | Subject will be on Formaflex for 2 weeks then crossover to Surfit Moldable Receives: Device: FormaFlex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to maintain secure (snug) fit around stoma
- Subject assessment of barrier fit based on questionnaire at each skin barrier change up to 2 weeks
- Barrier gap assessment performed by nurse at 2 weeks
- Barrier gap assessment performed by subject at each skin barrier change up to 2 weeks
Measured: Two weeks
Secondary outcomes (5)
Skin Protection
- SACS assessment by patient at each barrier change up to 2 weeks
- SACS assessment by nurse at 2 weeks
Measured: Two weeks
Wear Time
- Time of barrier change recorded
Measured: Two weeks
Ease of use
- Assessment by subject response to questionnaire
Measured: Two weeks
Ease of teaching
- Assessment by nurse of ability to teach subject to use barrier
Measured: Two weeks
Comfort
- Subject assessment of comfort of barrier at each change
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2012
- Study completionMay 2012
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
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Independent Nurse Consultants LLC
- Sponsor type
- University, hospital or other
- Collaborators
- ConvaTec Inc.
- Responsible party
- Sponsor
- Investigators
- Ann M Durnal, RN BSN WOCN, Principal investigator, Independent Nurse Consultants LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534039
- Sponsor's protocol ID
- INC#001
- Status last verified
- Sep 2013
- First submitted
- 19 Dec 2011
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4-A Clinical Comparison of a Marketed Moldable Skin Barrier Versus a Marketed Stretch-to-Fit Skin Barrier in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01534039
- Acronym / sponsor ID
- INC#001
- Conditions
- Peristomal Skin Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Independent Nurse Consultants LLCUniversity, hospital or other
- Collaborators
- ConvaTec Inc.
- Study start
- Dec 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Feb 2012 (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.
A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or urostomy.
Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin protection, wear-time, ease of use, ease of teaching, and comfort.
Detailed description
Study to include 60 subjects, three centers, total of 4 weeks, 2 weeks in each product. Subjects recruited from a population of persons who have had an existing fecal or urinary stoma for a duration of at least three months. There is no restriction on primary diagnosis for ostomy surgery. Subjects must be of legal consenting age, must currently be managing their own stoma with a two piece pouching system, either a pre-cut, cut to fit, moldable or stretch-to-fit, any manufacturer. Subjects may not require convexity and be willing to not to use any accessory products during the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sur-Fit Natura/FormaFlex | Active comparator | Device: Sur-Fit NaturaSubject will be on Surfit Moldable for 2 weeks then crossover to Formaflex |
| FormaFlex/Sur-Fit Natura | Active comparator | Device: FormaFlexSubject will be on Formaflex for 2 weeks then crossover to Surfit Moldable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Existing fecal or urinary ostomy for at least three months,consenting age, able to perform independent ostomy care, willing to not use accessory products, currently wearing a 2 piece marketed product.
- Able to participate for four weeks.
Key exclusion criteria (1 listed)
- Needing convexity.
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 |
|---|---|---|
| Sur-Fit NaturaAlso: ConvaTec Moldable Skin BarrierConvaTec Moldable Skin Barrier for ostomy patients | Device | Sur-Fit Natura/FormaFlex |
| FormaFlexAlso: Hollister FormaFlexHollister skin barrier for ostomy patients | Device | FormaFlex/Sur-Fit Natura |
Primary outcome
Ability to maintain secure (snug) fit around stoma
Time frame: Two weeks
1. Subject assessment of barrier fit based on questionnaire at each skin barrier change up to 2 weeks 2. Barrier gap assessment performed by nurse at 2 weeks 3. Barrier gap assessment performed by subject at each skin barrier change up to 2 weeks
5 secondary outcomes
Skin Protection
Time frame: Two weeks
Wear Time
Time frame: Two weeks
Ease of use
Time frame: Two weeks
Ease of teaching
Time frame: Two weeks
Comfort
Time frame: Two weeks
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 24 Sep 2013.
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.
Ann M Durnal, RN BSN WOCN principal investigator
Independent Nurse Consultants LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sur-Fit Natura and FormaFlex in people with Peristomal Skin Complication, run by Independent Nurse Consultants LLC 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 2 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 24 Sep 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ability to maintain secure (snug) fit around stoma (time frame: Two weeks). 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 24 Sep 2013.