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Randomized Controlled Trial Comparative Study
Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver.
- Roberto Biffi, Luca Fattori, Emilio Bertani, Davide Radice, Nicole Rotmensz, Pasquale Misitano, Sabine Cenciarelli, Antonio Chiappa, Liliana Tadini, Marina Mancini, Giovanni Pesenti, Bruno Andreoni, and Angelo Nespoli.
- Division of Abdomino-Pelvic and Minimally Invasive Surgery, European Institute of Oncology, Via G, Ripamonti, Milan, 435-20141, Italy. roberto.biffi@ieo.it
- World J Surg Oncol. 2012 Jan 1;10:94.
BackgroundAn antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery. We decided to test this finding in a randomized, double-blind trial.MethodsAdults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were randomly assigned to have the surgical incision dressed with Aquacel Ag Hydrofiber dressing or a common dressing. To blind the patient and the nursing and medical staff to the nature of the dressing used, scrub nurses covered Aquacel Ag Hydrofiber with a common wound dressing in the experimental arm, whereas a double common dressing was applied to patients of control group. The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery.ResultsA total of 112 patients (58 in the experimental arm and 54 in the control group) qualified for primary end-point analysis. The characteristics of the patient population and their surgical procedures were similar. The overall rate of surgical-site infection was lower in the experimental group (11.1% center 1, 17.5% center 2; overall 15.5%) than in controls (14.3% center 1, 24.2% center 2, overall 20.4%), but the observed difference was not statistically significant (P = 0.451), even with respect to surgical-site infection grade 1 (superficial) versus grades 2 and 3, or grade 1 and 2 versus grade 3.ConclusionsThis randomized trial did not confirm a statistically significant superiority of Aquacel Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery.Trial RegistrationClinicaltrials.gov: NCT00981110.
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