Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-06-19

Brief Summary

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The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.

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Detailed Description

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Conditions

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Colostomy Stoma Ileostomy - Stoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ostomy pouch

Ostomy pouch coated with novel technology

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Subjects with a colostomy or ileostomy

* Age 18 years and over
* Medically stable in the opinion of the investigator
* Are able and willing to provide informed consent
* Are able and willing to attend study visits
* Currently use the same models of pouches as required by the study
* Have a recent history of frequent pancaking (colostomy patients only)
* Willing to stop using any lubricants in the pouches whilst participating in the study.
* Subject has a valid email address for the Investigator to send links to study questionnaires and has access to a web enabled device.

Exclusion Criteria

* • Subjects with any peristomal skin condition classified as non-intact skin at the time of enrolment

* Subjects who maybe receiving any concomitant treatment and/or medications which could impact the consistency of effluent during the study period.
* Allergic to any components of the Novel Lubricant inclusive of Soyabean and/or Vitamin E.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No