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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02499588
Other study ID # CC-0509-15-U375
Secondary ID
Status Recruiting
Phase N/A
First received July 3, 2015
Last updated July 15, 2015
Start date June 2015

Study information

Verified date July 2015
Source ConvaTec Inc.
Contact Kim Peters, BSc (Hons)
Phone 07889841338
Email kim.peters@convatec.com
Is FDA regulated No
Health authority Poland: Ethics CommitteeUnited Kingdom: Research Ethics Committee
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Esteem Plus with ConvaTec Moldable Technology

Natura with ConvaTec Moldable Technology

Natura Accordion with ConvaTec Moldable Technology

Esteem synergy Plus with ConvaTec Moldable Technology


Locations

Country Name City State
Poland Voivodeship Specialistic Hospital in Gorzow Wlkp. Gorzow Wielkopolski Lubuskie

Sponsors (1)

Lead Sponsor Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peri-stomal skin condition at 8-15 days following the application of the barrier. Using SACs scale to determine incidence and severity of lesions 8-15 days No
Secondary 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 1 month (± 15 days) No
Secondary 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 2 months (± 15 days) No
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