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Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial.

ABSTRACT: Surgical site infections (SSIs) are the second most common form of nosocomial infection. Colorectal resections have high rates of SSIs secondary to the inherently contaminated intraluminal environment. Negative pressure wound therapy dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. No randomized control trials exist to support the use of negative pressure wound therapy following elective open colorectal resection to reduce surgical site infection.In this single-center, superiority designed prospective randomized open blinded endpoint controlled trial, patients scheduled for a colorectal resection via a laparotomy will be considered eligible. Patients undergoing laparoscopic resection will be enrolled but only randomized and included if the operation is converted to an open procedure. Exclusion criteria are patients receiving an abdominoperineal resection or a palliative procedure, as well as pregnant patients and those with an adhesive allergy. After informed consent, 300 patients will be randomized to the use of a standard adhesive gauze dressing or to a negative pressure wound device. Patients will be followed in hospital and reassessed on post-operative day 30. The primary outcome measure is SSI within the first 30 post-operative days. Secondary outcomes include the length of hospital stay, the number of return visits related to a potential or actual SSI, cost, and the need for homecare. The primary endpoint analysis follows the intention-to-treat principle.NEPTUNE is the first randomized controlled trial to investigate the role of incisional negative pressure wound therapy in decreasing the rates of surgical site infections in the abdominal incisions of patients following an elective, open colorectal resection. This low-risk intervention may help decrease the morbidity and costs associated with the development of an SSI in our patients.NCT02007018--clinicaltrials.gov; 5 December 2013.

SUBMITTER: Chadi SA

PROVIDER: S-EPMC4518608 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial.

Chadi Sami A SA Vogt Kelly N KN Knowles Sarah S Murphy Patrick B PB Van Koughnett Julie Ann JA Brackstone Muriel M Ott Michael C MC

Trials 20150730

<h4>Background</h4>Surgical site infections (SSIs) are the second most common form of nosocomial infection. Colorectal resections have high rates of SSIs secondary to the inherently contaminated intraluminal environment. Negative pressure wound therapy dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. No randomized control trials exist to support the use of negative pressure wound therapy following elective open colorectal re ...[more]

PMID: 26223227

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Project description:BACKGROUND:Surgical site infections (SSIs) remain a major source of morbidity and cost after resection of intra-abdominal malignancies. Negative-pressure wound therapy (NPWT) has been reported to significantly reduce SSIs when applied to the closed laparotomy incision. This article reports the results of a randomized clinical trial examining the effect of NPWT on SSI rates in surgical oncology patients with increased risk for infectious complications. STUDY DESIGN:From 2012 to 2016, two hundred and sixty-five patients who underwent open resection of intra-abdominal neoplasms were stratified into 3 groups: gastrointestinal (n = 57), pancreas (n = 73), or peritoneal surface (n = 135) malignancy. They were randomized to receive NPWT or standard surgical dressing (SSD) applied to the incision from postoperative days 1 through 4. Primary outcomes of combined incisional (superficial and deep) SSI rates were assessed up to 30 days after surgery. RESULTS:There were no significant differences in superficial SSIs (12.8% vs 12.9%; p > 0.99) or deep SSI (3.0% vs 3.0%; p > 0.99) rates between the SSD and NPWT groups, respectively. When stratified by type of surgery, there were still no differences in combined incisional SSI rates for gastrointestinal (25% vs 24%; p > 0.99), pancreas (22% vs 22%; p > 0.99), and peritoneal surface malignancy (9% vs 9%; p > 0.99) patients. When performing univariate and multivariate logistic regression analysis of demographic and operative factors for the development of combined incisional SSI, the only independent predictors were preoperative albumin (p = 0.0031) and type of operation (p = 0.018). CONCLUSIONS:Use of NPWT did not significantly reduce incisional SSI rates in patients having open resection of gastrointestinal, pancreatic, or peritoneal surface malignancies. Based on these results, at this time NPWT cannot be recommended as a therapeutic intervention to decrease infectious complications in these patient populations.

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Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial.

Publications

Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial.

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