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Efficacy of Integuseal for Surgical Skin Preparation in Children and Adolescents Undergoing Scoliosis Correction

Dromzee, Eric MD; Tribot-Laspière, Quentin MD; Bachy, Manon MD; Zakine, Serge MD; Mary, Pierre MD; Vialle, Raphaël MD, PhD

doi: 10.1097/BRS.0b013e3182687d6c
Deformity

Study Design. Prospective randomized trial.

Objective. To explore the use of a microbial sealant applied before the surgical incision to reduce surgical site infection in patients with scoliosis.

Summary of Background Data. The incidence of superficial or deep infections is reported in 2 groups of patients treated for neuromuscular or adolescent idiopathic scoliosis. Statistical analysis aimed to compare the effect of the use of a cyanoacrylate microbial sealant on infection rate.

Methods. From June 2010 to June 2011, 56 patients were prospectively enrolled in the study. Using a random number table, patients were assigned either to receive or not a sterile, film-forming cyanoacrylate liquid application (Integuseal). Epidemiological data and infection occurrence were compared in both groups.

Results. Statistical analysis comparing patients with neuromuscular scoliosis and adolescent idiopathic scoliosis showed that patients with neuromuscular scoliosis had more fused levels, increased intraoperative bleeding, and longer intraoperative time. Six patients had early postoperative infections of the posterior approach, which included 3 deep and 3 superficial infections. Five infections occurred in patients treated with Integuseal. Outcome was favorable in 6 cases after local wound debridement and antibiotics. Nonparametric statistical tests (Fisher exact test) showed no significant correlation (P = 0.096) between early postoperative infection occurrence and the use of Integuseal.

Conclusion. Although microbial sealant may be a useful addition to a multimodal approach to minimize surgical site infection, there is currently insufficient evidence as to whether the use of microbial sealants reduces the risk of surgical site infection in patients undergoing scoliosis surgery.

We studied the effect of a cyanoacrylate microbial sealant on the incidence of early postoperative infections in patients with scoliosis. Fifty-six patients were prospectively enrolled in a randomized trial. The trial demonstrated no significant correlation (P = 0.096) between early postoperative infection occurrence and the use of microbial sealant in scoliosis surgery.

From the Department of Pediatric Orthopaedics, Université Pierre et Marie Curie Paris 6, Armand Trousseau Hospital, Paris, France.

Address correspondence and reprint requests to Raphaël Vialle, MD, PhD, Department of Pediatric Orthopaedics, Université Pierre et Marie Curie Paris 6, Armand Trousseau Hospital, 26 avenue du Dr Arnold Netter, 75571 Paris Cedex 12, France; E-mail: raphael.vialle@trs.aphp.fr

Acknowledgment date: January 19, 2012. First revision date: April 22, 2012. Second revision date: June 24, 2012. Acceptance date: July 2, 2012.

The manuscript submitted does not contain information about medical device(s)/drug(s).

No funds were received in support of this work.

No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.

© 2012 Lippincott Williams & Wilkins, Inc.