Sterile versus nonsterile gloves for repair of uncomplicated lacerations in the emergency department: A randomized controlled trial☆
Received 6 January 2003; received in revised form 8 September 2003; accepted 17 September 2003.
Abstract
Study objective
Although sterile technique for laceration management continues to be recommended, studies supporting this practice are lacking. Using clean nonsterile gloves rather than individually packaged sterile gloves for uncomplicated wound repair in the emergency department may result in cost and time savings. This study is designed to determine whether the rate of infection after repair of uncomplicated lacerations in immunocompetent patients is comparable using clean nonsterile gloves versus sterile gloves.
Methods
A prospective multicenter trial enrolled 816 individuals who were randomized to have their wounds repaired by using sterile or clean nonsterile gloves. The attending physician or resident completed a checklist describing patient, wound, and management characteristics. The patients were provided with a questionnaire to be completed by the physician who removed their sutures at the prescribed time and indicated the presence or absence of infection. When follow-up forms were not returned, a telephone call was made to the patient to determine whether he or she had experienced any wound complications.
Results
Follow-up was obtained for 98% of the sterile gloves group and 96.6% of the clean gloves group. There was no statistically significant difference in the incidence of infection between the 2 groups. The infection rate in the sterile gloves group was 6.1% (95% confidence interval [CI] 3.8% to 8.4%) and was 4.4% in the clean gloves group (95% CI 2.4% to 6.4%). The relative risk of infection was 1.37 (95% CI 0.75 to 2.52).
Conclusion
This study demonstrated that there is no clinically important difference in infection rates between using clean nonsterile gloves and sterile gloves during the repair of uncomplicated traumatic lacerations.
aDepartment of Emergency Medicine, North York General Hospital, University of Toronto, Toronto, Ontario, Canada
bDepartment of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada
cDepartment of Emergency Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada
dDepartment of Family and Community Medicine, Division Emergency Medicine, McMaster University, Hamilton, Ontario, Canada
eDepartment of Emergency Medicine, Credit Valley Hospital, Toronto, Ontario, Canada
fDepartment of Emergency Medicine, William Osler Health Centre, Brampton, Ontario, Canada
gDepartment of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada
hOntario Cancer Institute, Princess Margaret Hospital, Toronto, Ontario, Canada
Address for reprints: Vsevolod S. Perelman, MD, MSc, Department of Emergency Medicine, North York General Hospital, 4001 Leslie Street, Toronto, Ontario, M2R 1E1 Canada; 416-650-1212
☆ Author contributions: VSP, GJF, and TR developed the study and received research funding. The study was designed and administrated by VSP and GJF. JF, FM, and TR were the site directors at their respective sites and also contributed to the final manuscript. GD was responsible for consultation about statistical analysis and also contributed to the development of the manuscript. VSP and GJF reviewed the literature and drafted the manuscript. TR and FM provided significant input into the final draft of the manuscript. VSP, GJF, and TR are the principal investigators by virtue of their significant involvement. VSP takes responsibility for the paper as a whole.
Preliminary results presented in poster format at the Section of Teachers and the Section of Researchers of the College of Family Physicians of Canada annual workshop; Montreal, Quebec, Canada; October 1999.
Completed study presented in poster format at the International Conference of Emergency Medicine; Edinburgh, Scotland; June 2002.
Awarded the Canadian Research Award for Family Medicine Residents by the Research Foundation of the College of Family Physicians of Canada and the Provincial Association of Interns and Residents of Ontario.
Supported by research grants from the Canadian Association of Emergency Physicians and the Bales Research Foundation of North York General Hospital.
The investigators did not receive any grants or financial support of any kind from any glove manufacturers or other pharmaceutical industry sources.