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.
RCT Entities:
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.
Authors: Maria B Schiavone; Lea Moukarzel; Kam Leong; Qin C Zhou; Anoushka M Afonso; Alexia Iasonos; Kara Long Roche; Mario M Leitao; Dennis S Chi; Nadeem R Abu-Rustum; Oliver Zivanovic Journal: Gynecol Oncol Date: 2017-07-19 Impact factor: 5.482
Authors: Shaheel Mohammad Sahebally; Kevin McKevitt; Ian Stephens; Fidelma Fitzpatrick; Joseph Deasy; John Patrick Burke; Deborah McNamara Journal: JAMA Surg Date: 2018-11-21 Impact factor: 14.766
Authors: Jolyn S Taylor; Claire A Marten; Mark F Munsell; Charlotte C Sun; Kimberly A Potts; Jennifer K Burzawa; Alpa M Nick; Larissa A Meyer; Keith Myers; Diane C Bodurka; Thomas A Aloia; Charles F Levenback; David R Lairson; Kathleen M Schmeler Journal: Ann Surg Oncol Date: 2016-08-29 Impact factor: 5.344
Authors: Benedikt Huttner; Ari A Robicsek; Pascal Gervaz; Eli N Perencevich; Eduardo Schiffer; Jacques Schrenzel; Stephan Harbarth Journal: Surg Infect (Larchmt) Date: 2012-12-16 Impact factor: 2.150