title: Topical sucralfate treatment of anal fistulotomy wounds: a randomized placebo-controlled trial.
abstract: 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.
  
  
  METHODS
  Double-blind, randomized controlled study comparing topical application of sucralfate or placebo.
  
  
  METHODS
  Private outpatient clinic specializing in anorectal disease in Nagpur, India.
  
  
  METHODS
  Patients with a wound length of at least 5 cm after low anal fistulotomy were eligible for the study.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Fine Morning Hospital and Research Center, Nagpur, India. drpjg@yahoo.co.in
authors.forename: Pravin J
authors.initials: PJ
authors.lastname: Gupta
authors.forename: Purushottam S
authors.initials: PS
authors.lastname: Heda
authors.forename: Subhash A
authors.initials: SA
authors.lastname: Shrirao
authors.forename: Surekha S
authors.initials: SS
authors.lastname: Kalaskar
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010919:Placebos; D012003:Rectal Fistula / Q000601:surgery*; D013392:Sucralfate / Q000008:administration & dosage*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D000897:Anti-Ulcer Agents; D010919:Placebos; D013392:Sucralfate