User Evaluation of the Peristomal Skin Condition in Ostom... | NCT02499588

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

NCT02499588

Sponsor

ConvaTec Inc.

Status

Unknown status

Last Update Posted

Jul 16, 2015Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Colostomy
Ileostomy
Urostomy

Interventions

Esteem Plus with ConvaTec Moldable Technology
Natura with ConvaTec Moldable Technology
Natura Accordion with ConvaTec Moldable Technology
Esteem synergy Plus with ConvaTec Moldable Technology

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Aug 2016Estimated

Completion Date

Not provided

First Submitted Date

Jul 3, 2015

First Submission Date that Met QC Criteria

Jul 15, 2015

First Posted Date

Jul 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2015

Last Update Posted Date

Jul 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esteem Plus with ConvaTec Moldable Technology	Device
Natura with ConvaTec Moldable Technology	Device
Natura Accordion with ConvaTec Moldable Technology	Device
Esteem synergy Plus with ConvaTec Moldable Technology	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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)
Peristomal skin condition in ostomates at 2 months (± 15 days) following the application of the barrier.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with colostomy, ileostomy or urostomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kim Peters, BSc (Hons)	Contact	07889841338		kim.peters@convatec.com
Caroline Butler, PhD	Contact	07710603969		caroline.butler@convatec.com

Overall Officials

Name	Affiliation	Role
Kim Peters, BSc (Hons)	Sponsor GmbH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Voivodeship Specialistic Hospital in Gorzow Wlkp.	Recruiting	Gorzów Wielkopolski	Lubusz Voivodeship	66-400	Poland

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.