User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™ (OSMOSE)

July 15, 2015 updated by: ConvaTec Inc.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lubuskie
      • Gorzow Wielkopolski, Lubuskie, Poland, 66-400
        • Recruiting
        • Voivodeship Specialistic Hospital in Gorzow Wlkp.
        • Contact:
          • Mariola Mikołajczak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with colostomy, ileostomy or urostomy

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8-15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peristomal skin condition in ostomates at 1 month (± 15 days) following the application of the barrier.
Time Frame: 1 month (± 15 days)
Using SACs scale to determine incidence and severity of lesions
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)
Using SACs scale to determine incidence and severity of lesions
2 months (± 15 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConvaTec Inc.

Investigators

  • Study Director: Kim Peters, BSc (Hons), Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

July 3, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-0509-15-U375

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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