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.
  
  
  METHODS
  Single-institution, randomized controlled trial with blinded assessment of main outcome. The trial opened in April 2007 and was closed in January 2010.
  
  
  METHODS
  Veterans Administration teaching hospital.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Surgical Services, Veterans Affairs North Texas Health Care System, 4500 S. Lancaster Road, Dallas, TX 75216, USA. thomas.anthony@va.gov
authors.forename: Thomas
authors.initials: T
authors.lastname: Anthony
authors.forename: Bryce W
authors.initials: BW
authors.lastname: Murray
authors.forename: John T
authors.initials: JT
authors.lastname: Sum-Ping
authors.forename: Fima
authors.initials: F
authors.lastname: Lenkovsky
authors.forename: Vadim D
authors.initials: VD
authors.lastname: Vornik
authors.forename: Betty J
authors.initials: BJ
authors.lastname: Parker
authors.forename: Jackie E
authors.initials: JE
authors.lastname: McFarlin
authors.forename: Kathleen
authors.initials: K
authors.lastname: Hartless
authors.forename: Sergio
authors.initials: S
authors.lastname: Huerta
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D003107:Colorectal Surgery / Q000009:adverse effects* / Q000379:methods; D005069:Evaluation Studies as Topic; D019317:Evidence-Based Medicine / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care / Q000379:methods; D011322:Primary Prevention / Q000379:methods; D012016:Reference Values; D018570:Risk Assessment; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D013530:Surgical Wound Infection / Q000517:prevention & control*; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome