Topical sucralfate treatment of anal fistulotomy wounds: a randomized placebo-controlled trial.

BACKGROUND: Sucralfate is a cytoprotective agent which adheres to mucoproteins and forms a protective barrier at wound sites. In oral form it is a common ulcer medication, and as a topical preparation it has been used to treat a wide variety of wounds. OBJECTIVE: The present study was designed to evaluate the effectiveness and safety of topical sucralfate in wound healing after anal fistulotomy. DESIGN: Double-blind, randomized controlled study comparing topical application of sucralfate or placebo. SETTING: Private outpatient clinic specializing in anorectal disease in Nagpur, India. PATIENTS: Patients with a wound length of at least 5 cm after low anal fistulotomy were eligible for the study. INTERVENTION: Patients were randomly assigned to receive ointment containing 7% sucralfate or a placebo ointment consisting of petroleum jelly. Patients were instructed to apply approximately 3 g of ointment to the wound twice daily after a sitz bath for 6 weeks or until the wound had healed. MAIN OUTCOME MEASURES: The wounds were examined by a blinded independent observer at 2, 4, and 6 weeks after the operation. The primary end point was the proportion of patients with wounds that had completely healed. Secondary end points included amount of mucosal covering (scored by the observer), adverse events, and postoperative pain (self-rated on a visual analog scale). RESULTS: Of 80 participants (29 women, 51 men; median age, 23 (range, 17-49) years), 76 participants completed the trial (sucralfate, 39; placebo, 37). At 6-week follow-up, complete wound healing was achieved in 37 patients (95%) in the sucralfate group and 27 patients (73%) in the placebo group (P = .009). Mucosal coverage of the wound was significantly greater with sucralfate than with placebo at each measurement point (P = .01). No adverse events were observed. Postoperative pain scores were significantly lower for sucralfate than for placebo at 2 and 4 weeks after the start of treatment. LIMITATIONS: Wound tissue specimens were not available for morphological and ultrastructural analysis. CONCLUSIONS: The results of this study add support to the evidence that topical sucralfate is a safe and effective method for promoting mucosal healing and for providing analgesia during wound treatment. Patients undergoing anal fistulotomy can benefit from the use of topical application of sucralfate.