title: Fibrin glue is effective healing perianal fistulas in patients with Crohn's disease.
abstract: OBJECTIVE
  Fibrin glue is a therapeutic for fistulas that activates thrombin to form a fibrin clot, which mechanically seals the fistula tract. We assessed the efficacy and safety of a heterologous fibrin glue that was injected into the fistula tracts of patients with Crohn's disease (ClinicalTrials.gov No. NCT00723047).
  
  
  METHODS
  This multicenter, open-label, randomized controlled trial included patients with a Crohn's disease activity index < or =250 and fistulas between the anus (or low rectum) and perineum, vulva, or vagina, that drained for more than 2 months. Magnetic resonance imaging or endosonography was performed to assess fistula tracts and the absence of abscesses. Patients were stratified into groups with simple or complex fistulas and randomly assigned to receive fibrin glue injections (n = 36) or only observation (n = 41) after removal of setons. The primary end point was clinical remission at week 8, defined as the absence of draining, perianal pain, or abscesses. At week 8, a fibrin glue injection was offered to patients who were not in remission.
  
  
  RESULTS
  Clinical remission was observed in 13 of the 34 patients (38%) of the fibrin glue group compared with 6 of the 37 (16%) in the observation group; these findings demonstrate the benefit of fibrin glue (odds ratio, 3.2; 95% confidence interval: 1.1-9.8; P = .04). The benefit seemed to be greater in patients with simple fistulas. Four patients in the fibrin glue group and 6 in the observation group had adverse events.
  
  
  CONCLUSIONS
  Fibrin glue injection is a simple, effective, and well-tolerated therapeutic option for patients with Crohn's disease and perianal fistula tracts.
authors.affiliation: Hôpital Nord, Centre d'investigation Clinique Marseille Nord, Université Méditerranée, Marseille, France. jean-charles.grimaud@ap-hm.fr
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Grimaud
authors.forename: Nicolas
authors.initials: N
authors.lastname: Munoz-Bongrand
authors.forename: Laurent
authors.initials: L
authors.lastname: Siproudhis
authors.forename: Laurent
authors.initials: L
authors.lastname: Abramowitz
authors.forename: Agnès
authors.initials: A
authors.lastname: Sénéjoux
authors.forename: Véronique
authors.initials: V
authors.lastname: Vitton
authors.forename: Luc
authors.initials: L
authors.lastname: Gambiez
authors.forename: Bernard
authors.initials: B
authors.lastname: Flourié
authors.forename: Xavier
authors.initials: X
authors.lastname: Hébuterne
authors.forename: Edouard
authors.initials: E
authors.lastname: Louis
authors.forename: Benoit
authors.initials: B
authors.lastname: Coffin
authors.forename: Vincent
authors.initials: V
authors.lastname: De Parades
authors.forename: Guillaume
authors.initials: G
authors.lastname: Savoye
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Soulé
authors.forename: Yoram
authors.initials: Y
authors.lastname: Bouhnik
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Colombel
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Contou
authors.forename: Yves
authors.initials: Y
authors.lastname: François
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Mary
authors.forename: Marc
authors.initials: M
authors.lastname: Lémann
mesh_terms: D000328:Adult; D003424:Crohn Disease / Q000150:complications*; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012003:Rectal Fistula / Q000628:therapy*
chemical_list: D015718:Fibrin Tissue Adhesive