OstomyOSMOSENCT01526967
Observational Evaluation of the Peristomal Skin Condition in Ostomates
An observational study of Ostomy, run by ConvaTec Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy
- How many people
- 2,000 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2012to Dec 2012
- 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: colostomates, ileostomates, urostomates in acute care settings or community at large.
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 a ConvaTec Moldable Technology™ Skin Barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.
- OR
- Subjects presenting with peristomal skin lesions using a traditional barrier and for whom a decision to replace the traditional barrier with ConvaTec Moldable Technology™ Skin Barrier per package insert is made in the context of routine clinical care.
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
13 sites in 1 country.
13 sites in 1 country
United States13 sites
San Jacinto Methodist Hospital
Baytown, Texas, 77521
Serena Group - Dr. Thomas Serena MD
Cambridge, Massachusetts, 02140
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038
ID Med Inc.
Columbus, Ohio, 43222
John Muir Health Concord Campus
Concord, California, 94520
Karmanos Cancer Center
Detroit, Michigan, 48201
Baptist Home Health
Jacksonville, Florida, 32207
RI Colorectal Clinic, LLC
Pawtucket, Rhode Island, 02860
Conn. Clinical Nursing Associate, LLC
Plymoth, Connecticut, 06782
NW Pavillion Ostomy Clinic
Renton, Washington, 98055
St. Anthony's Medical Center
St Louis, Missouri, 63128
Independent Nurse Consultant
Tucson, Arizona, 85742
Porter Hospital
Valparaiso, Indiana, 46383
About this study
Official title: Observational Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™ Skin Barriers
The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.
- Conditions
- Ostomy
- Keywords
- ostomy, peristomal skin breakdown, ConvaTec Moldable Skin Barriers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| New moldable user | Subjects presenting with peristomal lesions with a traditional barrier and for whom a ConvaTec Moldable Technology™ Skin Barrier is used as a replacement. | |
| New osomate | Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peristomal skin condition
Change in peristomal skin condition from baseline as assessed with the SACS Instrument
Measured: At day 12
Secondary outcomes (6)
Peristomal skin condition
Change in peristomal skin condition from baseline as assessed with the SACS instrument
Measured: at 1 month
Level of satisfaction
Subjects satisfaction as measured with a satisfaction survey
Measured: At 2 months
Accessory usage
Subjects use of additional products in stoma care.
Measured: Up to 2 months
Peristomal Skin Condition
Change in peristomal skin condition from baseline as assessed with the SACS instrument
Measured: At 2 months
Level of satisfaction
Subjects level of satisfaction as measured by a satisfaction survey
Measured: At 12 days
Level of satisfaction
Subjects level of satisfaction as measured with a satisfaction survey
Measured: At 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Li, Ph.D, MD, Study chair, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526967
- Sponsor's protocol ID
- MA-0509-12-U359
- Acronym
- OSMOSE
- Status last verified
- Dec 2012
- First submitted
- 1 Feb 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™ Skin Barriers
- ClinicalTrials.gov ID
- NCT01526967
- Acronym / sponsor ID
- OSMOSE / MA-0509-12-U359
- Conditions
- Ostomy
- Keywords
- ostomy, peristomal skin breakdown, ConvaTec Moldable Skin Barriers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 6 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.
The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New moldable user | – | –Subjects presenting with peristomal lesions with a traditional barrier and for whom a ConvaTec Moldable Technology™ Skin Barrier is used as a replacement. |
| New osomate | – | –Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colostomates, ileostomates, urostomates in acute care settings or community at large.
Key inclusion criteria (6 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 a ConvaTec Moldable Technology™ Skin Barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.
- OR
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.
Primary outcome
Peristomal skin condition
Time frame: At day 12
Change in peristomal skin condition from baseline as assessed with the SACS Instrument
6 secondary outcomes
Peristomal skin condition
Time frame: at 1 month
Level of satisfaction
Time frame: At 2 months
Accessory usage
Time frame: Up to 2 months
Peristomal Skin Condition
Time frame: At 2 months
Level of satisfaction
Time frame: At 12 days
Level of satisfaction
Time frame: At 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Qing Li, Ph.D, MD study chair
ConvaTec Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ostomy, run by ConvaTec Inc. at 13 sites 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 6 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Results are not available in the source record.
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: At day 12). 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 17 Dec 2012.