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. 2020 Nov 9;21(1):918.
doi: 10.1186/s13063-020-04831-z.

Negative pressure wound therapy (NPWT) on closed incisions to prevent surgical site infection in high-risk patients in hepatopancreatobiliary surgery: study protocol for a randomized controlled trial-the NP-SSI trial

Frank W Brennfleck  1 , Lena Linsenmeier  2 , Henrik H G Junger  2 , Katharina M Schmidt  2 , Jens M Werner  2 , Daniel Woehl  2 , Florian Zeman  3 , Ingrid Mutzbauer  2 , James A Hutchinson  2 , Edward K Geissler  2 , Hans J Schlitt  2 , Stefan M Brunner  2
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Negative pressure wound therapy (NPWT) on closed incisions to prevent surgical site infection in high-risk patients in hepatopancreatobiliary surgery: study protocol for a randomized controlled trial-the NP-SSI trial

Frank W Brennfleck et al. Trials. .

Abstract

Background: Incisional 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.

Methods: In 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.

Discussion: A 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 registration: This 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.

Keywords: HPB surgery; Incision management; NP-SSI; NPWT; Prevena; Randomized controlled trial; SSI; Wound infection; ciNPWT.

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Conflict of interest statement

In recent years, author Frank Brennfleck has given several lectures on behalf of KCI at training events for medical professionals and has twice acted as a consultant for the company. In total, he received about 7500 Euro from the company from 2016 to 2020. The remaining authors have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Applied PREVENA™ PEEL & PLACE™ dressing on a patients’ wound, connected to the PREVENA PLUS™ device. The 20-cm long dressing covers the median laparotomy. The Prevena™ Plus device is connected to the dressing via a thin plastic tube and provides a vacuum of − 125 mmHg
Fig. 2
Fig. 2
Current CDC-Classification of superficial and deep-incisional Surgical Site Infections. The primary endpoint will be assessed according to the criteria mentioned above
Fig. 3
Fig. 3
Study timeline. Patients who meet the inclusion criteria will be asked for their consent after information. At the end of the operation, the participants are randomized, and the intervention is performed according to the treatment group. During visit 3 the bandages are removed on day 7 and the endpoints are recorded as on days 30–37
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