ColostomyOSMOSENCT02499588
User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
An observational study of Colostomy and Ileostomy, run by ConvaTec Inc. at 1 site in Poland.
Trial summary
The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Esteem Plus with ConvaTec Moldable Technology, Natura with ConvaTec Moldable Technology and Natura Accordion with ConvaTec Moldable Technology
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2015to Aug 2016
- 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 with colostomy, ileostomy or urostomy
Who may be able to join
- Subjects who are 18 years old and older.
- Subjects who agree to participate in the evaluation and who have signed the informed consent form.
- Subjects presenting with a stoma (ileostomy, colostomy or urostomy).
- Subjects for whom ConvaTec Moldable Technology™ per package insert, within the context of routine clinical care is used as the first long-term (within 7 days of ostomy surgery) system following surgery and who have intact peristomal skin (healthy or SACs L1).
Who cannot join
- Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem.
- Subjects who are in a simultaneous clinical evaluation.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Voivodeship Specialistic Hospital in Gorzow Wlkp.
Gorzów Wielkopolski, Lubusz Voivodeship, 66-400
Mariola Mikołajczak
About this study
Official title: Observational User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care following surgery.
- Being tested
- Esteem Plus with ConvaTec Moldable Technology, Natura with ConvaTec Moldable Technology, Natura Accordion with ConvaTec Moldable Technology, Esteem synergy Plus with ConvaTec Moldable Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esteem Plus with ConvaTec Moldable TechnologyDevice
Natura with ConvaTec Moldable TechnologyDevice
Natura Accordion with ConvaTec Moldable TechnologyDevice
Esteem synergy Plus with ConvaTec Moldable TechnologyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-stomal skin condition at 8-15 days following the application of the barrier.
Using SACs scale to determine incidence and severity of lesions
Measured: 8-15 days
Secondary outcomes (2)
Peristomal skin condition in ostomates at 1 month (± 15 days) following the application of the barrier.
Using SACs scale to determine incidence and severity of lesions
Measured: 1 month (± 15 days)
Peristomal skin condition in ostomates at 2 months (± 15 days) following the application of the barrier.
Using SACs scale to determine incidence and severity of lesions
Measured: 2 months (± 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColostomyStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim Peters, BSc (Hons), Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499588
- Sponsor's protocol ID
- CC-0509-15-U375
- Acronym
- OSMOSE
- Status last verified
- Jul 2015
- First submitted
- 3 Jul 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
- ClinicalTrials.gov ID
- NCT02499588
- Acronym / sponsor ID
- OSMOSE / CC-0509-15-U375
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (estimated)
- First posted
- 16 Jul 2015 (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 primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care following surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with colostomy, ileostomy or urostomy
Key inclusion criteria (4 listed)
- Subjects who are 18 years old and older.
- Subjects who agree to participate in the evaluation and who have signed the informed consent form.
- Subjects presenting with a stoma (ileostomy, colostomy or urostomy).
- Subjects for whom ConvaTec Moldable Technology™ per package insert, within the context of routine clinical care is used as the first long-term (within 7 days of ostomy surgery) system following surgery and who have intact peristomal skin (healthy or SACs L1).
Key exclusion criteria (2 listed)
- Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem.
- Subjects who are in a simultaneous clinical evaluation.
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 |
|---|---|---|
| Esteem Plus with ConvaTec Moldable Technology | Device | – |
| Natura with ConvaTec Moldable Technology | Device | – |
| Natura Accordion with ConvaTec Moldable Technology | Device | – |
| Esteem synergy Plus with ConvaTec Moldable Technology | Device | – |
Primary outcome
Peri-stomal skin condition at 8-15 days following the application of the barrier.
Time frame: 8-15 days
Using SACs scale to determine incidence and severity of lesions
2 secondary outcomes
Peristomal skin condition in ostomates at 1 month (± 15 days) following the application of the barrier.
Time frame: 1 month (± 15 days)
Peristomal skin condition in ostomates at 2 months (± 15 days) following the application of the barrier.
Time frame: 2 months (± 15 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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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.
Kim Peters, BSc (Hons) study director
Sponsor GmbH
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 Colostomy and Ileostomy, run by ConvaTec Inc. at 1 site in Poland.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Jul 2015. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Peters, BSc (Hons) (07889841338, kim.peters@convatec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-stomal skin condition at 8-15 days following the application of the barrier. (time frame: 8-15 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 16 Jul 2015.