Sprague, N Engl J Med 2024 - Skin Antisepsis before Surgical Fixation of Extremity Fractures

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Skin Antisepsis before Surgical Fixation of Extremity Fractures

PREP-IT Investigators, The PREP-IT Investigators, et al.·N Engl J Med·2024·57 citations·RCT

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Background

Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture).

Methods

In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures.
Every 2 months, the hospitals alternated interventions.
Separate populations of patients with either open or closed fractures were enrolled and included in the analysis.
The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days.
The secondary outcome was unplanned reoperation for fracture-healing complications.

Results

A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial.
In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049).
In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45).
The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups.

Conclusions

Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).

Copyright remains with the authors and publisher.

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Skin Antisepsis before Surgical Fixation of Extremity Fractures

PREP-IT Investigators, The PREP-IT Investigators, et al.·N Engl J Med·2024·57 citations·RCT

|

Background

Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture).

Methods

In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures.
Every 2 months, the hospitals alternated interventions.
Separate populations of patients with either open or closed fractures were enrolled and included in the analysis.
The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days.
The secondary outcome was unplanned reoperation for fracture-healing complications.

Results

A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial.
In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049).
In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45).
The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups.

Conclusions

Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).

Copyright remains with the authors and publisher.

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