Trauma
Sterile versus nonsterile gloves for repair of uncomplicated lacerations in the emergency department: A randomized controlled trial

https://doi.org/10.1016/j.annemergmed.2003.09.008Get rights and content

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.

Introduction

Lacerations are a common problem treated in the emergency department (ED). Sterile technique continues to be recommended and taught as the “correct” surgical approach for treating lacerations, despite the lack of evidence to support this practice. Current practice often involves using clean nonsterile gloves during the preparatory phase and sterile gloves for the surgical repair. Adherence to strict sterile technique is time consuming and can, in some instances, necessitate the use of an assistant.

Capsule Summary

What is already known on this topic

Sterile technique is generally used for laceration repair despite the lack of scientific evidence that it is necessary.

What question this study addressed

The infection rate of lacerations was compared in 816 patients randomized to receive repair using sterile versus nonsterile gloves.

What this study adds to our knowledge

There was no difference in infection rates when nonsterile gloves were used.

How this might change clinical practice

Use of nonsterile gloves for laceration repair could save time and money without increasing the risk of infection.

In contrast to surgical incisions, traumatic lacerations are invariably contaminated with bacteria from various sources, including skin flora and the lacerating object. In a busy ED environment, sterility of the operative field is often breached when, for example, the patient moves or the physician reaches for additional suture material or gauze or contacts a nonprepared area of the body.

The rationale for use of traditional sterile technique has recently been questioned in various areas of medical1, 2, 3, 4 and dental5, 6, 7 care.

Three studies have revealed that tap water can be safely used for cleansing traumatic wounds in the emergency setting.8, 9, 10 Ruthman et al11 demonstrated that laceration repairs without using caps or masks did not lead to increased infection rates. Bodiwala and George12 have shown that even without using gloves, infection rates after the repair of simple lacerations were not increased compared with repairs using sterile gloves. In a nonrandomized, nonblinded study of 50 lacerations, Worral13 compared the infection rates of wounds repaired with sterile or nonsterile gloves and found no difference. The use of nonsterile, clean gloves has also been shown to be safe in certain procedures in burn patients4 and in the ICU.3

Although published guidelines14, 15 recommend sterile technique for laceration management, there is little evidence to support this method as a standard of care. A preliminary survey of 18 emergency and 24 family physicians conducted by the authors revealed that more than 70% often used nonsterile gloves or had experienced sterile-field violations during repairs of lacerations (GJ Francis, VS Perelman, unpublished data, 1999). A review of the literature did not reveal any prospective, randomized, blinded study comparing sterile and nonsterile gloves for repair of uncomplicated lacerations in the ED.

Section snippets

Study design

Our hypothesis was that using clean nonsterile gloves for the repair of uncomplicated lacerations in immunocompetent patients does not lead to an increase in the incidence of wound infections. This prospective, randomized, multicentered trial included all patients who consented to participate, were older than 1 year, and presented to the ED with any type of uncomplicated soft tissue lacerations. Patients were excluded if there was presence of diabetes mellitus, renal failure, asplenia,

Results

One thousand one hundred people with lacerations were approached to enroll in the study (Figure). Nine hundred and two patients consented to participate. Of those patients, 86 were excluded (Figure).

There were no differences in the baseline characteristics of the clean-boxed and sterile glove study groups (Table 1). Men constituted 72.9% of the study patients. The sites of lacerations were extremities in 61.8% of patients, head or neck in 36.6% of patients, and trunk or buttocks in 1.6% of

Limitations

The study was designed to measure precision around the absolute difference in infection rates between the 2 groups. The target sample size in this study was 800 patients equally randomized into 2 arms. With such a sample size, the absolute difference in infection rates between groups was measured with a precision that extends to ±2.8%, with a 95% probability. The sample size required for an equivalency trial with similar characteristics was in excess of 3,000 patients per group,19 which was

Discussion

The present study of 816 randomized laceration repairs did not generate any data to suggest that infections are more common when lacerations are repaired with nonsterile gloves.

The number of patients with lacerations who presented to the 3 sites throughout the study period was approximately 9,000. Approximately 10% of those patients were approached with the intent of enrollment, 1,147 were assessed, 86 were excluded, and 245 refused to participate in the study.

The demographic data did not

Acknowledgements

We thank Edmee Franseen, MSc, for contributing her invaluable expertise in statistics. We also thank C. Cheung, MD, for assisting with the study, Kimberly Francis, RN, for her assistance in data entry, and A. Worster, MD, and M. Ackerman, MD, for their review and valuable suggestions during the preparation of the manuscript.

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  • Cited by (0)

    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.

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