Timing of surgical antimicrobial prophylaxis: a phase 3 randomised controlled trial.
- Weber WP Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: walter.weber@usb.ch.
- Mujagic E Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- Zwahlen M Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
- Bundi M Department of General Surgery, Hospital of Aarau, Aarau, Switzerland.
- Hoffmann H Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- Soysal SD Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- Kraljević M Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- Delko T Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- von Strauss M Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland; Department of General Surgery, Hospital of Aarau, Aarau, Switzerland.
- Iselin L Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- Da Silva RXS Department of General Surgery, Hospital of Aarau, Aarau, Switzerland.
- Zeindler J Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- Rosenthal R University of Basel, Basel, Switzerland.
- Misteli H Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- Kindler C Department of Anaesthesiology, Hospital of Aarau, Aarau, Switzerland.
- Müller P Department of Anaesthesiology, Hospital of Aarau, Aarau, Switzerland.
- Saccilotto R University of Basel, Basel, Switzerland; Department of Clinical Research, University Hospital Basel, Basel, Switzerland.
- Lugli AK University of Basel, Basel, Switzerland; Department of Anaesthesiology, University Hospital Basel, Basel, Switzerland.
- Kaufmann M University of Basel, Basel, Switzerland; Department of Anaesthesiology, University Hospital Basel, Basel, Switzerland.
- Gürke L Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- von Holzen U Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland; Indiana University School of Medicine South Bend, Goshen Center for Cancer Care, Goshen, IN, USA; Harper Cancer Research Institute, South Bend, IN, USA.
- Oertli D Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- Bucheli-Laffer E Department of Infectious Diseases, Hospital of Aarau, Aarau, Switzerland.
- Landin J Department of General Surgery, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
- Widmer AF University of Basel, Basel, Switzerland; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.
- Fux CA Department of Infectious Diseases, Hospital of Aarau, Aarau, Switzerland.
- Marti WR Department of General Surgery, Hospital of Aarau, Aarau, Switzerland.
- 2017-04-08
Published in:
- The Lancet. Infectious diseases. - 2017
Adolescent
Adult
Aged
Anti-Bacterial Agents
Anti-Infective Agents
Cefuroxime
Drug Administration Schedule
Female
Humans
Male
Metronidazole
Middle Aged
Risk Factors
Surgical Wound Infection
Treatment Outcome
English
BACKGROUND
Based on observational studies, administration of surgical antimicrobial prophylaxis (SAP) for the prevention of surgical site infection (SSI) is recommended within 60 min before incision. However, the precise optimum timing is unknown. This trial compared early versus late administration of SAP before surgery.
METHODS
In this phase 3 randomised controlled superiority trial, we included general surgery adult inpatients (age ≥18 years) at two Swiss hospitals in Basel and Aarau. Patients were randomised centrally and stratified by hospital according to a pre-existing computer-generated list in a 1:1 ratio to receive SAP early in the anaesthesia room or late in the operating room. Patients and the outcome assessment team were blinded to group assignment. SAP consisted of single-shot, intravenous infusion of 1·5 g of cefuroxime, a commonly used cephalosporin with a short half-life, over 2-5 min (combined with 500 mg metronidazole in colorectal surgery). The primary endpoint was the occurrence of SSI within 30 days of surgery. The main analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01790529.
FINDINGS
Between Feb 21, 2013, and Aug 3, 2015, 5580 patients were randomly assigned to receive SAP early (2798 patients) or late (2782 patients). 5175 patients (2589 in the early group and 2586 in the late group) were analysed. Median administration time was 42 min before incision in the early group (IQR 30-55) and 16 min before incision in the late group (IQR 10-25). Inpatient follow-up rate was 100% (5175 of 5175 patients); outpatient 30-day follow-up rate was 88·8% (4596 of 5175), with an overall SSI rate of 5·1% (234 of 4596). Early administration of SAP did not significantly reduce the risk of SSI compared with late administration (odds ratio 0·93, 95% CI 0·72-1·21, p=0·601).
INTERPRETATION
Our findings do not support any narrowing of the 60-min window for the administration of a cephalosporin with a short half-life, thereby obviating the need for increasingly challenging SAP timing recommendations.
FUNDING
Swiss National Science Foundation, Hospital of Aarau, University of Basel, Gottfried und Julia Bangerter-Rhyner Foundation, Hippocrate Foundation, and Nora van Meeuwen-Häfliger Foundation.
Based on observational studies, administration of surgical antimicrobial prophylaxis (SAP) for the prevention of surgical site infection (SSI) is recommended within 60 min before incision. However, the precise optimum timing is unknown. This trial compared early versus late administration of SAP before surgery.
METHODS
In this phase 3 randomised controlled superiority trial, we included general surgery adult inpatients (age ≥18 years) at two Swiss hospitals in Basel and Aarau. Patients were randomised centrally and stratified by hospital according to a pre-existing computer-generated list in a 1:1 ratio to receive SAP early in the anaesthesia room or late in the operating room. Patients and the outcome assessment team were blinded to group assignment. SAP consisted of single-shot, intravenous infusion of 1·5 g of cefuroxime, a commonly used cephalosporin with a short half-life, over 2-5 min (combined with 500 mg metronidazole in colorectal surgery). The primary endpoint was the occurrence of SSI within 30 days of surgery. The main analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01790529.
FINDINGS
Between Feb 21, 2013, and Aug 3, 2015, 5580 patients were randomly assigned to receive SAP early (2798 patients) or late (2782 patients). 5175 patients (2589 in the early group and 2586 in the late group) were analysed. Median administration time was 42 min before incision in the early group (IQR 30-55) and 16 min before incision in the late group (IQR 10-25). Inpatient follow-up rate was 100% (5175 of 5175 patients); outpatient 30-day follow-up rate was 88·8% (4596 of 5175), with an overall SSI rate of 5·1% (234 of 4596). Early administration of SAP did not significantly reduce the risk of SSI compared with late administration (odds ratio 0·93, 95% CI 0·72-1·21, p=0·601).
INTERPRETATION
Our findings do not support any narrowing of the 60-min window for the administration of a cephalosporin with a short half-life, thereby obviating the need for increasingly challenging SAP timing recommendations.
FUNDING
Swiss National Science Foundation, Hospital of Aarau, University of Basel, Gottfried und Julia Bangerter-Rhyner Foundation, Hippocrate Foundation, and Nora van Meeuwen-Häfliger Foundation.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1016/S1473-3099(17)30176-7
- PMID 28385346
- Persistent URL
- https://sonar.ch/global/documents/278482
Export to…
Statistics
Document views: 72
File downloads:
- Full-text: 0