Evidence map›Paper›PMID 33168081›Full record

ArticleTrials2020

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, Lena Linsenmeier, Henrik H G Junger, Katharina M Schmidt, Jens M Werner, Daniel Woehl, Florian Zeman, Ingrid Mutzbauer, James A Hutchinson, Edward K Geissler and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 1 institution in 1 country.

Frank W BrennfleckDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany. frank.brennfleck@klinik.uni-regensburg.de.ORCID http://orcid.org/0000-0001-8055-9282
Lena LinsenmeierDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
Henrik H G JungerDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
Katharina M SchmidtDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
Jens M WernerDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
Daniel WoehlDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
Florian ZemanCenter for Clinical Trials, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93053, Regensburg, Germany.
Ingrid MutzbauerDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
James A HutchinsonDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
Edward K GeisslerDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
Hans J SchlittDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
Stefan M BrunnerDepartment of Surgery, University Hospital Regensburg, Franz-Josef-Strauß Allee 11, 93053, Regensburg, Germany.
University Hospital Regensburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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 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.

Indexed as

Negative-Pressure Wound TherapySurgical Wound InfectionHumansProspective StudiesQuality of LifeRandomized Controlled Trials as TopicWound HealingciNPWTHPB surgeryIncision managementNP-SSINPWTPrevenaRandomized controlled trialSSIWound infection

Identifiers

PMID33168081
PMCPMC7654160
OpenAlexW3100628088

What OpenQuestion holds

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Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.