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Effect of a single prophylactic preoperative oral antibiotic dose on surgical site infection following complex dermatological procedures on the nose and ear: a prospective, randomised, controlled, double-blinded trial
  1. Helena Rosengren1,2,3,
  2. Clare F Heal4,
  3. Petra G Buttner5
  1. 1 College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia
  2. 2 Skin Cancer College of Australasia, Brisbane, Queensland, Australia
  3. 3 Skin Repair Skin Cancer Clinic, Townsville, Queensland, Australia
  4. 4 College of Medicine and Dentistry, James Cook University, Mackay, Queensland, Australia
  5. 5 Centre for Chronic Disease Prevention, James Cook University, Cairns, Queensland, Australia
  1. Correspondence to Dr Clare F Heal; Clare.Heal{at}


Objectives There is limited published research studying the effect of antibiotic prophylaxis on surgical site infection (SSI) in dermatological surgery, and there is no consensus for its use in higher-risk cases. The objective of this study was to determine the effectiveness of a single oral preoperative 2 g dose of cephalexin in preventing SSI following flap and graft dermatological closures on the nose and ear.

Design Prospective double-blinded, randomised, placebo-controlled trial testing for difference in infection rates.

Setting Primary care skin cancer clinics in North Queensland, Australia, were randomised to 2 g oral cephalexin or placebo 40–60 min prior to skin incision.

Participants 154 consecutive eligible patients booked for flap or graft closure following skin cancer excision on the ear and nose.

Intervention 2 g dose of cephalexin administered 40–60 min prior to surgery.

Results Overall 8/69 (11.6%) controls and 1/73 (1.4%) in the intervention group developed SSI (p=0.015; absolute SSI reduction 10.2%; number needed to treat (NNT) for benefit 9.8, 95% CI 5.5 to 45.5). In males, 7/44 controls and 0/33 in the intervention group developed SSI (p=0.018; absolute SSI reduction 15.9%; NNT for benefit 6.3, 95% CI 3.8 to 19.2). SSI was much lower in female controls (1/25) and antibiotic prophylaxis did not further reduce this (p=1.0). There was no difference between the study groups in adverse symptoms attributable to high-dose antibiotic administration (p=0.871).

Conclusion A single oral 2 g dose of cephalexin given before complex skin closure on the nose and ear reduced SSI.

Trial registration number ANZCTR 365115; Post-results.

  • antibiotic prophylaxis
  • surgical site infection
  • dermatologic surgical wound infection
  • operative surgical procedures
  • flaps
  • grafts
  • ear
  • nose

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  • Contributors HR established and oversaw the study design and implementation and compiled the data. CFH assisted with study design and analysis. PGB led the sample size calculation and study analysis. All authors contributed to the manuscript production.

  • Funding The Skin Cancer College of Australasia has provided funding to cover pharmaceutical costs associated with filling generic capsules with either active antibiotic or inert powder (placebo).

  • Disclaimer The funding body has not been involved in any way in the study design, data collection, data analysis, writing of the paper or making decisions regarding its publication.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval This randomised double-blinded placebo controlled trial was approved by the Human Research Ethics Committee of the Townsville Hospital and Health Service (approval number HREC/13/QTHS/61, May 2013) and registered with the Australian New Zealand Clinical Trial Registry (ACTRN12613001253796).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data sharing can be discussed with the corresponding author.

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