Fibrin glue is effective healing perianal fistulas in patients with Crohn's disease.
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.
Grimaud
Jean-Charles
JC
Hôpital Nord, Centre d'investigation Clinique Marseille Nord, Université Méditerranée, Marseille, France. jean-charles.grimaud@ap-hm.fr
Munoz-Bongrand
Nicolas
N
Siproudhis
Laurent
L
Abramowitz
Laurent
L
Sénéjoux
Agnès
A
Vitton
Véronique
V
Gambiez
Luc
L
Flourié
Bernard
B
Hébuterne
Xavier
X
Louis
Edouard
E
Coffin
Benoit
B
De Parades
Vincent
V
Savoye
Guillaume
G
Soulé
Jean-Claude
JC
Bouhnik
Yoram
Y
Colombel
Jean-Frédéric
JF
Contou
Jean-François
JF
François
Yves
Y
Mary
Jean-Yves
JY
Lémann
Marc
M
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*
D015718:Fibrin Tissue Adhesive