Insertion of a collagen plug to close an abdominal wall enterocutaneous fistula

4.1 In a case series of 6 patients, 100% (6/6) of fistulas had closed at 2 weeks but the fistula recurred in 33% (2/6) of patients. In both patients, the fistulas recurred at 9 months. The first patient died from postoperative complications after additional surgical repairs (no further details provided). For the second patient, after a short period of drainage, the procedure was repeated without any further recurrence at 6‑month follow‑up. In a case series of 5 patients, 40% (2/5) of fistulas closed after a few days. Of those that did not close, 67% (2/3) were closed by further treatment (timing not reported) without any further recurrence at 18‑month median follow‑up (range 8 to 29 months). In a second case series of 5 patients, 80% (4/5) of fistulas had closed by 80‑day mean follow‑up (range 30 to 120 days). In the remaining patient 2 separate procedures were done, 1 week apart, but the fistula did not close.

4.2 The specialist advisers stated that the key efficacy outcomes are permanent fistula closure and avoiding the need for surgical repair.