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.
Subject(s)
Colorectal Surgery/adverse effects , Evidence-Based Medicine/methods , Surgical Wound Infection/prevention & control , Adult , Aged , Aged, 80 and over , Analysis of Variance , Colorectal Surgery/methods , Evaluation Studies as Topic , Female , Follow-Up Studies , Humans , Logistic Models , Male , Middle Aged , Preoperative Care/methods , Primary Prevention/methods , Reference Values , Risk Assessment , Single-Blind Method , Statistics, Nonparametric , Survival Analysis , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: The purpose of this study was to compare risk factors for the development of incisional versus organ/space infections in patients undergoing colorectal surgery. METHODS: An institutional review board-approved retrospective review was performed examining a 4-year period (January 2002 to December 2005). Patients were included if they had undergone abdominal operations (open or laparoscopic) in which the colon/rectum was surgically manipulated. Patients were excluded if the surgical wound was not closed primarily. A standardized definition of incisional and organ/space infection was employed. RESULTS: A total of 428 operations were performed. Overall, 105 infections were identified (25%); 73 involved the incision and 32 were classified as organ/space. Multivariate analysis suggested that incisional infection was independently associated with body mass index (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.02-1.11) and creation/revision/reversal of an ostomy (OR, 2.2; 95% CI, 1.3-3.9). Organ/space infection was independently associated with perioperative transfusion (OR, 2.3; 95% CI, 1.1-5.5) and with previous abdominal surgery (OR, 2.5; 95% CI, 1.2-5.3). CONCLUSIONS: Factors associated with infection differed based on the type of surgical site infection being considered. The lack of overlap between factors associated with incisional infection and organ/space infection suggests that separate risk models and treatment strategies should be developed.
