PURPOSE: The treatment of fistulas-in-ano with fibrin sealant injection has been moderately successful. Failures can be caused by persistent infection within the tract or early expulsion of the clot. In an attempt to improve the success rate, we examined three modifications of the sealant procedure: the addition of cefoxitin to the sealant, surgical closure of the primary opening, or both. METHODS: A prospective, randomized, clinical trial was performed in which patients were treated with Tisseel-VH fibrin sealant according to previously published procedures. In addition, patients were randomized to receive intra-adhesive cefoxitin, surgical closure of the primary opening, or both modifications. Cefoxitin, 100 mg, was added to the sealant for patients randomized to receive intra-adhesive antibiotics. For the appropriate patients, the primary fistula opening was closed with a 3-0 absorbable suture. If fistulas failed to heal, patients were offered a single retreatment with sealant. RESULTS: Twenty-four patients were treated in the cefoxitin arm, 25 in the closure arm, and 26 in the combined arm. Median duration of fistulas was 12 months. Patients were followed for a mean of 27 months postoperatively. There was no postoperative incontinence or complications related to the sealant itself. Initial healing rates were 21 percent in the cefoxitin arm, 40 percent in the closure arm, and 31 percent in the combined arm (P = 0.35). One of five patients in the cefoxitin arm, one of seven patients in the closure arm, and one of six patients in the combined arm were successfully retreated; final healing rates were 25, 44, and 35 percent respectively (P = 0.38). CONCLUSIONS: Treatment of fistula-in-ano with fibrin sealant with closure of the internal opening was somewhat more successful than sealant with cefoxitin or the combination, however this did not achieve statistical significance. None of the three modifications were more successful than historic controls at our institution treated with sealant alone. Therefore, the addition of intra-adhesive cefoxitin, closure of the internal opening, or both are not recommended modifications of the fibrin sealant procedure.
RCT Entities:
PURPOSE: The treatment of fistulas-in-ano with fibrin sealant injection has been moderately successful. Failures can be caused by persistent infection within the tract or early expulsion of the clot. In an attempt to improve the success rate, we examined three modifications of the sealant procedure: the addition of cefoxitin to the sealant, surgical closure of the primary opening, or both. METHODS: A prospective, randomized, clinical trial was performed in which patients were treated with Tisseel-VH fibrin sealant according to previously published procedures. In addition, patients were randomized to receive intra-adhesive cefoxitin, surgical closure of the primary opening, or both modifications. Cefoxitin, 100 mg, was added to the sealant for patients randomized to receive intra-adhesive antibiotics. For the appropriate patients, the primary fistula opening was closed with a 3-0 absorbable suture. If fistulas failed to heal, patients were offered a single retreatment with sealant. RESULTS: Twenty-four patients were treated in the cefoxitin arm, 25 in the closure arm, and 26 in the combined arm. Median duration of fistulas was 12 months. Patients were followed for a mean of 27 months postoperatively. There was no postoperative incontinence or complications related to the sealant itself. Initial healing rates were 21 percent in the cefoxitin arm, 40 percent in the closure arm, and 31 percent in the combined arm (P = 0.35). One of five patients in the cefoxitin arm, one of seven patients in the closure arm, and one of six patients in the combined arm were successfully retreated; final healing rates were 25, 44, and 35 percent respectively (P = 0.38). CONCLUSIONS: Treatment of fistula-in-ano with fibrin sealant with closure of the internal opening was somewhat more successful than sealant with cefoxitin or the combination, however this did not achieve statistical significance. None of the three modifications were more successful than historic controls at our institution treated with sealant alone. Therefore, the addition of intra-adhesive cefoxitin, closure of the internal opening, or both are not recommended modifications of the fibrin sealant procedure.
Authors: A Amato; C Bottini; P De Nardi; P Giamundo; A Lauretta; A Realis Luc; G Tegon; R J Nicholls Journal: Tech Coloproctol Date: 2015-09-16 Impact factor: 3.781
Authors: J R Cintron; H Abcarian; V Chaudhry; M Singer; S Hunt; E Birnbaum; M G Mutch; J Fleshman Journal: Tech Coloproctol Date: 2012-09-28 Impact factor: 3.781