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

URN to cite this document:

urn:nbn:de:bvb:355-epub-450545 Copy

DOI to cite this document:

10.5283/epub.45054 Copy

Brennfleck, Frank W. ; Linsenmeier, Lena ; Junger, Henrik H.G. ; Schmidt, Katharina M. ; Werner, Jens M. ; Woehl, Daniel ; Zeman, Florian ; Mutzbauer, Ingrid ; Hutchinson, James A. ; Geissler, Edward K. ; Schlitt, Hans J. ; Brunner, Stefan M.

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Date of publication of this fulltext: 23 Feb 2021 12:28

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Details

Item type:	Article
Open Access Type:	DEAL (Springer Gold)
Journal or Publication Title:	Trials
Publisher:	BMC
Place of Publication:	LONDON
Volume:	21
Page Range:	p. 918
Date:	9 November 2020
Institutions:	Medicine > Lehrstuhl für Chirurgie Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Identification Number:	Value Type 10.1186/s13063-020-04831-z DOI
Keywords:	COMPLICATIONS; RESECTION; PREVALENCE; RECURRENCE; LAPAROTOMY; MANAGEMENT; DRESSINGS; OUTCOMES; IMPACT; NP-SSI; SSI; NPWT; ciNPWT; Incision management; Prevena; Wound infection; HPB surgery; Randomized controlled trial
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	45054

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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 ...

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 30days 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.

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Metadata last modified: 29 Sep 2021 07:42

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