Evaluating an evidence-based bundle for preventing surgical site infection: A randomized trial

Thomas Anthony, Bryce W. Murray, John T. Sum-Ping, Fima Lenkovsky, Vadim D. Vornik, Betty J. Parker, Jackie E. McFarlin, Kathleen Hartless, Sergio Huerta

Research output: Contribution to journalArticle

157 Citations (Scopus)

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. Trial Registration: clinicaltrials.gov Identifier: NCT00953784.

Original languageEnglish (US)
Pages (from-to)263-269
Number of pages7
JournalArchives of Surgery
Volume146
Issue number3
DOIs
StatePublished - Mar 2011

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Surgical Wound Infection
Outcome Assessment (Health Care)
United States Department of Veterans Affairs
Colorectal Surgery
Intention to Treat Analysis
Evidence-Based Practice
Infection Control
Teaching Hospitals
Multivariate Analysis
Randomized Controlled Trials
Confidence Intervals
Oxygen
Infection

ASJC Scopus subject areas

  • Surgery

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Evaluating an evidence-based bundle for preventing surgical site infection : A randomized trial. / Anthony, Thomas; Murray, Bryce W.; Sum-Ping, John T.; Lenkovsky, Fima; Vornik, Vadim D.; Parker, Betty J.; McFarlin, Jackie E.; Hartless, Kathleen; Huerta, Sergio.

In: Archives of Surgery, Vol. 146, No. 3, 03.2011, p. 263-269.

Research output: Contribution to journalArticle

Anthony, Thomas ; Murray, Bryce W. ; Sum-Ping, John T. ; Lenkovsky, Fima ; Vornik, Vadim D. ; Parker, Betty J. ; McFarlin, Jackie E. ; Hartless, Kathleen ; Huerta, Sergio. / Evaluating an evidence-based bundle for preventing surgical site infection : A randomized trial. In: Archives of Surgery. 2011 ; Vol. 146, No. 3. pp. 263-269.
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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. Trial Registration: clinicaltrials.gov Identifier: NCT00953784.",
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AB - 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. Trial Registration: clinicaltrials.gov Identifier: NCT00953784.

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