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The Effect of Prophylactic Antibiotics in Primary Palatoplasty Procedures

S. Alex Rottgers MD, Liliana Camison MD, Rick Mai MD, Sameer Shakeer BS, Lorelei Grunwaldt MD, Andrew Nowalk MD PhD, Joseph E. Losee MD
University of Pittsburgh Medical Center
2014-03-14

Presenter: S. Alex Rottgers

Affidavit:
I drafted the survey, obtained contact information for subject of the survey, distributed the survey, and am currently analyzing the data.

Director Name: Joseph E. Losee

Author Category: Resident Plastic Surgery
Presentation Category: Clinical
Abstract Category: Craniomaxillofacial

Background: Current literature does not demonstrate if prophylactic antibiotics are beneficial in cleft palate surgery. We sought to investigate if prophylactic antibiotics are beneficial in palate surgery.

Methods: A prospective, randomized, double-blinded controlled trial compared the rates of palatal infections, delayed healing, and palatal fistula formation in primary uncomplicated palatoplasties. Randomized patients received a single dose of unasyn or placebo. Patients underwent Furlow palatoplasties performed by 2 surgeons. Additionally, a retrospective study was conducted of the senior author's (JEL) consecutive 10-year (2004-2014) series of primary palatoplasties with the same endpoints.

Results: The prospective trial included 82 patients. 43 received Unasyn; 39 received placebo. No palatal infections were observed. Delayed healing occured in 14% of Unasyn and 20.5% of placebo patients (p=0.43). Fistulas formed in 2.3% and 5.1% of Unasyn and placebo patients respectively (p=0.50). One placebo patient developed a persistent Group A, beta-hemolytic streptococcal bacteremia requiring antibiotic treatment. The case did not meet the CDC definition of a surgical site infection, but the patient subsequently developed a palatal fistula on follow-up. 310 patients were studied in the retrospective cohort with no palatal infections detected. 146 patients received preop antibiotics and 165 did not. Delayed healing and fistula rates did not differ between groups: 18.5% vs 14.0% (p=0.28) and 7.5% vs 3.6% (p=0.13).

Conclusion: Preoperative prophylactic antibiotics do not affect the rates of palatal infection, delayed healing, and fistulas in primary palatoplasties. The significance of one case of postoperative streptococcal bacteremia and its implications for recommendations of antibiotic use remain unclear.

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