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Phase II Randomized Trial of Negative-Pressure Wound Therapy to Decrease Surgical Site Infection in Patients Undergoing Laparotomy for Gastrointestinal, Pancreatic, and Peritoneal Surface Malignancies.

ABSTRACT: 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.

SUBMITTER: Shen P

PROVIDER: S-EPMC5498990 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Phase II Randomized Trial of Negative-Pressure Wound Therapy to Decrease Surgical Site Infection in Patients Undergoing Laparotomy for Gastrointestinal, Pancreatic, and Peritoneal Surface Malignancies.

Shen Perry P Blackham Aaron U AU Lewis Stacey S Clark Clancy J CJ Howerton Russell R Mogal Harveshp D HD Dodson Rebecca M RM Russell Gregory B GB Levine Edward A EA

Journal of the American College of Surgeons 20170111 4

<h4>Background</h4>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.<h4>Study design</h4>From 2012 to 201 ...[more]

PMID: 28088597

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Project description:BackgroundPostoperative surgical site infection (SSI) is one of the most common hospital infections and contributes substantially to postoperative morbidity and mortality. In addition, SSIs dramatically increase the treatment cost and length of hospital stay. Following visceral surgery by laparotomy, SSI rates are especially high (14-25%). Therefore, measures to prevent SSI in this field are urgently needed. Prophylactic intraoperative wound irrigation (IOWI) of the subcutaneous soft tissue before skin closure hypothetically represents an easy and economical option to reduce SSI rates and is already frequently used in clinical practice. However, there are currently no definite recommendations on the use of IOWI since high-level evidence supporting its use is lacking. Consequently, clinical practice varies widely. Antiseptic polyhexanide (PHX)-based solutions are approved for soft-tissue wound irrigation in surgery but have not been specifically evaluated in randomized clinical trials for the prevention of SSI following laparotomy for visceral surgery.Methods/designThe IOWISI trial is a multicentre, randomized, observer- and patient-blinded clinical trial with three parallel treatment groups, comparing IOWI with a 0.04% PHX solution to no irrigation (test 1) or saline (test 2) before skin closure after laparotomy for visceral surgery (contamination level II-IV). The primary endpoint of the trial is the SSI rate within 30 days postoperatively. Statistical analysis of the primary endpoint measure will be based on the intention-to-treat population. The global level of significance is set at 2.5% for test 1 and 5% for test 2 and the sample size (n = 540) is determined to assure a power of 94% (test 1) and 85% (test 2).DiscussionThe IOWISI trial will provide high-level evidence as a basis for clinical recommendations regarding the use of IOWI with PHX or saline and will potentially impact on future clinical guidelines and practice. The pragmatic trial design guarantees high external validity.Trial registrationRegistered at the German Clinical Trials Register, DRKS00012251 . Registered on 3 July 2017.

Project description: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.

Project description:BACKGROUND:Organ/space surgical site infection (OS-SSI) develops frequently after trauma laparotomies and is associated with significant morbidity. No valid model exists to accurately risk-stratify the probability of OS-SSI development after emergent laparotomy. Risk stratification for OS-SSI in these patients could guide promising, but unproven, interventions for OS-SSI prevention, such as more frequent dosing of intraoperative antibiotics or direct peritoneal resuscitation. We hypothesize that in trauma patients who undergo emergent laparotomy, probability of OS-SSI can be accurately estimated using patient data available during the index operation. METHODS:Retrospective review was performed on a prospectively maintained database of emergent trauma laparotomies from 2011 to 2016. Patient demographics and risk factors for OS-SSI were collected. We performed Bayesian multilevel logistic regression to develop the model based on a 70% training sample. Evaluation of model fit using area under the curve was performed on a 30% test sample. The Bayesian approach allowed the model to address clustering of patients within physician while implementing regularization to improve predictive performance on test data. RESULTS:One hundred seventy-two (15%) of 1,171 patients who underwent laparotomy developed OS-SSI. Variables thought to affect development of surgical site infections and were available to the surgeon near the conclusion of the trauma laparotomy were included in the model. Two variables that contributed most to OS-SSIs were damage-control laparotomy and colon resection. The area under the curve of the predictive model validated on the test sample was 0.78 (95% confidence interval, 0.71-0.85). CONCLUSION:Using a combination of factors available to surgeons before the end of an emergent laparotomy, the probability of OS-SSI could be accurately estimated using this retrospective cohort. A Web-based calculator is under design to allow the real-time estimation of probability of OS-SSI intraoperatively. Prospective validation of its generalizability to other trauma cohorts and of its utility at the point of care is required. LEVEL OF EVIDENCE:Prognostic study, level IV.

Dataset Information

Phase II Randomized Trial of Negative-Pressure Wound Therapy to Decrease Surgical Site Infection in Patients Undergoing Laparotomy for Gastrointestinal, Pancreatic, and Peritoneal Surface Malignancies.

Publications

Phase II Randomized Trial of Negative-Pressure Wound Therapy to Decrease Surgical Site Infection in Patients Undergoing Laparotomy for Gastrointestinal, Pancreatic, and Peritoneal Surface Malignancies.

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