Novel Post-Surgical Incision Management to Prevent Ostomy Complications

NARecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

November 18, 2024

Primary Completion Date

January 31, 2029

Study Completion Date

March 31, 2029

Conditions
OstomyEnterocutaneous Fistula
Interventions
DEVICE

Limpet

Limpet participants will have their device placed by a clinician. Upon discharge, a portable vacuum pump will be issued to provide negative pressure (e.g., 3M Prevena or Snap; ConvaTec Avelle; or Pensar MicroDoc). These systems are compact, fit in a pocket, are simple to operate, and commonly used in the outpatient setting to provide multiple weeks of therapy. Participants will be furnished with materials to address potential dressing problems while at home: extra waste pouches, adhesive drape strips for sealing air leaks, and standard of care adhesive ostomy pouches and accessories as a backup plan in the event of a Limpet failure.

DEVICE

Control

Control participants will receive standard of care adhesive ostomy pouch dressings. Participants will be furnished with materials to address potential dressing problems while at home: adhesive ostomy pouches and accessories for pouch replacement. The Control group will change their pouches at home 2 to 5 times per week or more frequently if needed, as per the current standard of care.

Trial Locations (1)

55101

RECRUITING

Regions Hospital, Saint Paul

All Listed Sponsors
lead

HealthPartners Institute

OTHER