NCT02499588

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

July 3, 2015

Last Update Submit

July 15, 2015

Conditions

ColostomyIleostomyUrostomy

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Peristomal skin condition in ostomates at 1 month (± 15 days) following the application of the barrier.

    1 month (± 15 days)

  • Peristomal skin condition in ostomates at 2 months (± 15 days) following the application of the barrier.

    2 months (± 15 days)

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with colostomy, ileostomy or urostomy

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Voivodeship Specialistic Hospital in Gorzow Wlkp.

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

RECRUITING

Study Officials

  • Kim Peters, BSc (Hons)

    Sponsor GmbH

    STUDY DIRECTOR

Central Study Contacts

Kim Peters, BSc (Hons)

CONTACT

07889841338kim.peters@convatec.com

Caroline Butler, PhD

CONTACT

07710603969caroline.butler@convatec.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2015

First Posted

July 16, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

PL(1)