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

Colostomy Clinical Trial

— OSMOSE  

Official title:

Observational User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02499588
• Other study ID #: CC-0509-15-U375
• 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. 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

• Colostomy
• Ileostomy
• Skin Diseases
• Urostomy

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