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

INTRODUCTION

Approximately 1 million people live with ileostomies and rely on stoma bags in their daily lives. They do not have access to alternative products. To address alternatives, InterPoc™, an absorbent intestinal tampon, has been developed. However, its safety and efficacy in humans have not yet been assessed.

AIM: This study aimed to evaluate the safety and efficiency of InterPoc by assessing pain, vital parameters, mucosal lesions and tampon insertion/removal.

METHOD: Eight adults with ileostomies were enrolled in a pilot safety study. InterPoc was inserted into the stoma and stayed in for a maximum of 6 hours; it was removed earlier if discomfort was reported. Over this period, all participants fasted but were allowed to drink up to 2 litres of clear fluids. Hourly examinations were conducted to assess vital signs, pain and discomfort. All patients received a follow-up phone call 24 hours after removal of InterPoc.

RESULTS

Eight participants were included of 21 who were screened. The InterPoc tampon had a median insertion duration of 3 hours and a median removal weight of 58.5 grams. One participant had the InterPoc inserted for 6 hours. No mucosal lesions, ischaemia, bleeding or major complications were registered during the observation period. No pain or discomfort was reported 24 hours after InterPoc removal. Vital signs remained stable with no Early Warning Score (EWS) higher than 1.

CONCLUSION

The study demonstrated that InterPoc was safe and well tolerated in adults with an ileostomy, with no reported complications during the 24-hour follow-up period.