Evidence map›Paper›PMID 29288184›Full record

Trial reportBMJ open2017

LEAK study: design of a nationwide randomised controlled trial to find the best way to treat wound leakage after primary hip and knee arthroplasty.

Claudia A M Löwik, Frank-Christiaan Wagenaar, Walter van der Weegen, Rudolf W Poolman, Rob G H H Nelissen, Sjoerd K Bulstra, Yvette Pronk, Karin M Vermeulen, Marjan Wouthuyzen-Bakker, Inge van den Akker-Scheek and 3 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.0field-weighted citation impact, top 9% 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

9 citing papers in PubMed, 29 citations in OpenAlex.

  1. Observational
  2. Article
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  6. Review
  7. Observational
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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

13 authors at 6 institutions in 1 country.

Claudia A M LöwikDepartment of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0002-3532-537X
Frank-Christiaan WagenaarOCON, Center for Orthopaedic Surgery, Hengelo, The Netherlands.
Walter van der WeegenDepartment of Orthopaedic Surgery, Sint Anna Ziekenhuis, Geldrop, The Netherlands.
Rudolf W PoolmanDepartment of Orthopaedic Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Rob G H H NelissenDepartment of Orthopaedic Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Sjoerd K BulstraDepartment of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Yvette PronkResearch Department, Kliniek Viasana, Mill, The Netherlands.
Karin M VermeulenDepartment of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Marjan Wouthuyzen-BakkerDepartment of Medical Microbiology and Infection Prevention, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Inge van den Akker-ScheekDepartment of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Martin StevensDepartment of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Paul C JutteDepartment of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
LEAK study group
University Medical Center Groningen · NLKliniek ViaSana · NLLeiden University Medical Center · NLOCON Orthopedische kliniek · NLOLVG · NLSt. Anna Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTotal hip arthroplasty (THA) and total knee arthroplasty (TKA) are highly successful treatment modalities for advanced osteoarthritis. However, prolonged wound leakage after arthroplasty is linked to prosthetic joint infection (PJI), which is a potentially devastating complication. On the one hand, wound leakage is reported as a risk factor for PJI with a leaking wound acting as a METHODS AND ANALYSIS: A prospective nationwide randomised controlled trial will be conducted in 35 hospitals in the Netherlands. The goal is to include 388 patients with persistent wound leakage 9-10 days after THA or TKA. These patients will be randomly allocated to non-surgical treatment (pressure bandages, (bed) rest and wound care) or surgical treatment (debridement, antibiotics and implant retention (DAIR)). DAIR will also be performed on all non-surgically treated patients with persistent wound leakage at day 16-17 after index surgery, regardless of amount of wound leakage, other clinical parameters or C reactive protein. Clinical data are entered into a web-based database. Patients are asked to fill in questionnaires about disease-specific outcomes, quality of life and cost effectiveness at 3, 6 and 12 months after surgery. Primary outcome is the number of revision surgeries due to infection within a year of arthroplasty. ETHICS AND DISSEMINATION: The Review Board of each participating hospital has approved the local feasibility. The results will be published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NTR5960;Pre-results.

Indexed as

Anti-Bacterial AgentsArthroplasty, Replacement, HipArthroplasty, Replacement, KneeDebridementHumansLogistic ModelsNetherlandsOsteoarthritisProspective StudiesProsthesis-Related InfectionsQuality of LifeReoperationResearch DesignSurgical WoundAnti-Bacterial AgentsCost EffectivenessDairJoint ArthroplastyPeriprosthetic Joint InfectionRandomized Controlled TrialWound Management

Identifiers

PMID29288184
PMCPMC5770823
OpenAlexW2783728368

What OpenQuestion holds

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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.