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

Convatec

Status: Completed

Conditions: Ileostomy - Stoma; Colostomy Stoma

Treatments: Device: Ostomy pouch

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06394115

OC-21-419

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.