Abstract
BackgroundIncisional surgical site infections (iSSI) in hepatopancreatobiliary (HPB) surgery usually lead to prolonged hospital stays, consume valuable resources, and impact on patients’ outcome. Prophylactic closed incision negative pressure wound therapy (ciNPWT) to decrease wound complications has become available. Owing to an increasing number of studies, evidence for superiority in many indication areas has accumulated; however, in general surgery, there are a few data and those have shown contradictory results.MethodsIn this monocentric, prospective, randomized, controlled, two-armed study, the influence of ciNPWT on incisional surgical site infection rates after HPB operations will be investigated. A total of 222 patients will be randomized 1:1 to an interventional group (7-day treatment with ciNPWT) or a control group (treated with gauze dressing). The primary parameter to evaluate efficacy is the rate of incisional SSIs within 30 days after surgery. Additionally, several clinically relevant secondary outcomes will be assessed.DiscussionA reduction in the rate of incisional SSIs would not only lead to a significant cost reduction and shorter postoperative length of stay, but may also improve postoperative quality of life for patients. While earlier publications have shown advantages for ciNPWT, recent studies did not confirm a positive effect regarding iSSI rate. Even if iSSI rate is not reduced, findings obtained from the secondary endpoints may be of clinical relevance, such as reduction of wound complication rates.Trial registrationThis trial has been registered in the German Clinical Trials Register, DRKS 00015136. Registered on 19 February 2019 and has been approved by the local ethics committee of the University of Regensburg: 18-1225-101.
Highlights
Incisional surgical site infections in hepatopancreatobiliary (HPB) surgery usually lead to prolonged hospital stays, consume valuable resources, and impact on patients’ outcome
Primary endpoint The primary aim of this study is to investigate if closed incision negative pressure wound therapy (ciNPWT) provided by the PrevenaTM Incision Management System (KCI, San Antonio, Texas) reduces the incidence of superficial and deep incisional surgical site infection within 30 days after HPB surgery, compared to standard of care using a sterile gauze dressing
After major open operations, such as HPB surgery, Incisional surgical site infections (iSSI) occur at a frequency of 8–31.5%, depending on type of operation and wound contamination class [12, 42]
Summary
Prospective, randomized, controlled, two-armed study, the influence of ciNPWT on incisional surgical site infection rates after HPB operations will be investigated. A total of 222 patients will be randomized 1:1 to an interventional group (7-day treatment with ciNPWT) or a control group (treated with gauze dressing). The primary parameter to evaluate efficacy is the rate of incisional SSIs within 30 days after surgery. Several clinically relevant secondary outcomes will be assessed
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