Objective: We evaluated a new fistula and wound management system; ostomy and wound care nurses were queried about willingness to use the product in future patients, product wear time and pouch leakage, perifistular skin condition, access for wound care, pouching time, patient mobility and comfort, odor management, pouch flexibility, adhesiveness, and erosion. A health economic assessment was also done.
Method: Twenty-two patients (5 males and 17 females) with an abdominal fistula participated in the study. Participants tested 75 pouches, representing an average of 3.4 pouches per subject. The investigator at each site who performed the pouch changes completed a questionnaire at baseline, during the test, and after testing the pouches. Participants also completed a set of questions after each test pouch was removed.
Results: In 21 of 22 cases, the nurses would consider using the new system on future patients. After each pouch removal, patients were asked whether they were able to move around while wearing the test pouch and they answered yes 95% of the time. The new system was found to have significantly longer wear time than traditional systems (P = .003), but the average time spent on changing the pouches was not significantly different (P = .07). Access for fistula and wound care was rated as excellent in the new pouching system, and comfort was rated as very good.
Conclusion: The results of the study suggest that all of the key requests received from nurses for an improved system for fistula and wound management were met by the new system.
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