Clinical Trial
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Perioperative Bundle to Reduce Surgical Site Infection after Pancreaticoduodenectomy: A Prospective Cohort Study.

BACKGROUND: Pancreaticoduodenectomy is historically associated with incisional surgical site infection (iSSI) rates between 15% and 20%. Prospective studies have been mixed with respect to the benefit of individual interventions directed at decreasing iSSI. We hypothesized that the application of a perioperative bundle during pancreaticoduodenectomy would decrease the rate of iSSIs significantly.

METHODS: An initial cohort of 150 consecutive post-pancreaticoduodenectomy patients were assessed within 2 to 4 weeks of operation to determine baseline iSSI rates. The CDC definition of iSSI was used. A 4-part perioperative bundle was then instituted for the second cohort of 150 patients. This bundle consisted of a double-ring wound protector, gown/glove and drape change before fascial closure, irrigation of the wound with bacitracin solution, and a negative-pressure wound dressing that was left in place until postoperative day 7 or day of discharge. Three-hundred patients provided 80% power to detect a 50% risk reduction in iSSIs.

RESULTS: Cohorts 1 and 2 were similar with respect to age (68 vs 69 years; p = 0.918), sex (male, 51% vs 55%; p = 0.644), BMI (26 vs 26 kg/m2 ; p = 0.928), use of neoadjuvant therapy (21% vs 17%; p = 0.377), median operative time (222 vs 215 minutes; p = 0.366), and presence of a preoperative stent (53% vs 41%; p = 0.064). The iSSI rate was 22.3% in the initial cohort. This rate was higher than both our institutional database (13%) and NSQIP reporting (11%). Within the second cohort, the iSSI rate decreased significantly to 10.7% (n = 16; p = 0.012). All 4 components of the bundle were used in 91% of cohort 2 patients.

CONCLUSIONS: In this cohort study of 300 consecutive patients who underwent pancreaticoduodenectomy, the implementation of a 4-part bundle decreased iSSI rate from 22% to 11%.

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