Evaluating a novel intestinal tampon for adults with ileostomy: pilot study

Area of Science:

• Gastroenterology
• Medical Devices
• Patient Care

Background:

• Over 1 million people worldwide live with ileostomies, relying on stoma bags.
• There is a lack of alternative products for ileostomists.
• InterPoc, an absorbent intestinal tampon, has been developed as a potential alternative.

Purpose of the Study:

• To evaluate the safety and efficiency of InterPoc in adult ileostomists.
• To assess pain, vital parameters, and mucosal integrity during and after InterPoc use.
• To determine the feasibility of InterPoc as an alternative to stoma bags.

Main Methods:

• A pilot safety study involving eight adult ileostomists.
• InterPoc insertion for up to 6 hours with hourly monitoring.
• Assessment of pain, vital signs, and mucosal lesions.
• 24-hour follow-up via phone call.

Main Results:

• InterPoc was used for a median of 3 hours, with one participant using it for 6 hours.
• No mucosal lesions, ischemia, bleeding, or major complications were observed.
• No pain or discomfort was reported post-removal, and vital signs remained stable.

Conclusions:

• InterPoc is safe and well-tolerated in adults with ileostomies.
• The absorbent intestinal tampon showed no adverse effects during the study period.
• InterPoc presents a promising alternative for ileostomy management.