@article{7144, author = {Thomas Anthony and Bryce W. Murray and John T. Sum-Ping and Fima Lenkovsky and Vadim D. Vornik and Betty J. Parker and Jackie E. McFarlin and Kathleen Hartless and Sergio Huerta}, title = {Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial.}, abstract = {

OBJECTIVE: To determine if an evidence-based practice bundle would result in a significantly lower rate of surgical site infections (SSIs) when compared with standard practice.

DESIGN: Single-institution, randomized controlled trial with blinded assessment of main outcome. The trial opened in April 2007 and was closed in January 2010.

SETTING: Veterans Administration teaching hospital.

PATIENTS: Patients who required elective transabdominal colorectal surgery were eligible. A total of 241 subjects were approached, 211 subjects were randomly allocated to 1 of 2 interventions, and 197 were included in an intention-to-treat analysis.

INTERVENTIONS: Subjects received either a combination of 5 evidenced-based practices (extended arm) or were treated according to our current practice (standard arm). The interventions in the extended arm included (1) omission of mechanical bowel preparation; (2) preoperative and intraoperative warming; (3) supplemental oxygen during and immediately after surgery; (4) intraoperative intravenous fluid restriction; and (5) use of a surgical wound protector.

MAIN OUTCOME MEASURE: Overall SSI rate at 30 days assessed by blinded infection control coordinators using standardized definitions.

RESULTS: The overall rate of SSI was 45% in the extended arm of the study and 24% in the standard arm (P = .003). Most of the increased number of infections in the extended arm were superficial incisional SSIs (36% extended arm vs 19% standard arm; P = .004). Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk (95% confidence interval, 1.36-4.56; P = .003) independent of other factors traditionally associated with SSI.

CONCLUSIONS: An evidence-based intervention bundle did not reduce SSIs. The bundling of interventions, even when the constituent interventions have been individually tested, does not have a predictable effect on outcome. Formal testing of bundled approaches should occur prior to implementation.

}, year = {2011}, journal = {Arch Surg}, volume = {146}, pages = {263-9}, month = {03/2011}, issn = {1538-3644}, doi = {10.1001/archsurg.2010.249}, language = {eng}, }