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Does single application of topical chloramphenicol to high risk sutured wounds reduce incidence of wound infection after minor surgery? Prospective randomised placebo controlled double blind trial

BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.a2812 (Published 15 January 2009) Cite this as: BMJ 2009;338:a2812
  1. Clare F Heal, senior lecturer1,
  2. Petra G Buettner, senior lecturer2,
  3. Robert Cruickshank, general practitioner3,
  4. David Graham, general practitioner3,
  5. Sheldon Browning, general practitioner4,
  6. Jayne Pendergast, practice nurse3,
  7. Herwig Drobetz, staff orthopaedic surgeon5,
  8. Robert Gluer, medical student1,
  9. Carl Lisec, surgical registrar6
  1. 1James Cook University, School of Medicine, Mackay Base Hospital, Queensland 4740, Australia
  2. 2James Cook University, Queensland 4811
  3. 3Walkerston Medical Centre, Mackay, Queensland 4740
  4. 4Molescan, Mackay, Queensland 4740
  5. 5Mackay Base Hospital, Queensland 4740
  6. 6Townsville General Hospital, Queensland 4740
  1. Correspondence to: C F Heal clare.heal{at}jcu.edu.au
  • Accepted 4 October 2008

Abstract

Objective To determine the effectiveness of a single application of topical chloramphenicol ointment in preventing wound infection after minor dermatological surgery.

Design Prospective randomised placebo controlled double blind multicentre trial.

Setting Primary care in a regional centre in Queensland, Australia.

Participants 972 minor surgery patients.

Interventions A single topical dose of chloramphenicol (n=488) or paraffin ointment (n=484; placebo).

Main outcome measure Incidence of infection.

Results The incidence of infection in the chloramphenicol group (6.6%; 95% confidence interval 4.9 to 8.8) was significantly lower than that in the control group (11.0%; 7.9 to 15.1) (P=0.010). The absolute reduction in infection rate was 4.4%, the relative reduction was 40%, and the relative risk of wound infection in the control group was 1.7 (95% confidence interval 1.1 to 2.5) times higher than in the intervention group. The number needed to treat was 22.8.

Conclusion Application of a single dose of topical chloramphenicol to high risk sutured wounds after minor surgery produces a moderate absolute reduction in infection rate that is statistically but not clinically significant.

Trial registration Current Controlled Trials ISRCTN73223053.

Footnotes

  • We thank Jill Thistlethwaite, Margaret Wilson, Toni Kelly, Vicki Abela, Julie Sullivan, Debbie Kimber, Karen Nicholls, Susan Hodgens, Jan Hanson, Erik Van Der Linde, John Mackintosh, Andrew O’Neill, Andrea Cosgrove, Luke Notley, Maria-Renne Bouton, Stephen Sammut, Amanda Maloney, Sarah Nickl, and PHCRED Townsville. We gratefully acknowledge the RACGP Research Foundation for their support of this project.

  • Contributors: CFH conceived and designed the study and analysed and interpreted the data. PGB did the sample size calculation and statistical analysis. SB, RC, CL, HD, and DG contributed to the study design. All authors contributed to the manuscript. CFH is the guarantor.

  • Funding: Research was funded by the Chris Silagy scholarship from the Royal Australian College of General Practice. The authors’ work is independent of this funding.

  • Competing interests: None declared.

  • Ethical approval: The study was approved by the James Cook University ethics committee (approval number H2590). All patients provided written informed consent.

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

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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