Observational Evaluation of the Peristomal Skin Condition in Ostomates

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01526967

Acronym

OSMOSE

Enrollment

2000

Registered

2012-02-06

Start date

2012-01-31

Completion date

2012-12-31

Last updated

2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ostomy

Keywords

ostomy, peristomal skin breakdown, ConvaTec Moldable Skin Barriers

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 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.

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.

Design outcomes

Primary

Measure	Time frame	Description
Peristomal skin condition	At day 12	Change in peristomal skin condition from baseline as assessed with the SACS Instrument

Secondary

Measure	Time frame	Description
Peristomal skin condition	at 1 month	Change in peristomal skin condition from baseline as assessed with the SACS instrument
Level of satisfaction	At 2 months	Subjects satisfaction as measured with a satisfaction survey
Accessory usage	Up to 2 months	Subjects use of additional products in stoma care.
Peristomal Skin Condition	At 2 months	Change in peristomal skin condition from baseline as assessed with the SACS instrument

Countries

United States

Outcome results