Evidence map›Paper›PMID 34696784›Full record

ArticleTrials2021

Negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI-2 trial): study protocol for a pragmatic, multicentre, cross surgical specialty, randomised controlled trial.

Ian Chetter, Catherine Arundel, Belen Corbacho Martin, Catherine Hewitt, Caroline Fairhurst, Kalpita Joshi, Andrew Mott, Sara Rodgers, Pedro Saramago Goncalves, David Torgerson and 11 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 30% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
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  4. Trial
  5. Article
  6. Review
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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

21 authors at 1 institution in 1 country.

Ian ChetterYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Catherine ArundelYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK. catherine.arundel@york.ac.uk.ORCID http://orcid.org/0000-0003-0512-4339
Belen Corbacho MartinYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Catherine HewittYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Caroline FairhurstYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Kalpita JoshiYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Andrew MottYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Sara RodgersYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Pedro Saramago GoncalvesYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
David TorgersonYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Jacqueline WilkinsonYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Jane BlazebyYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Rhiannon MacefieldYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Stephen DixonYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Eileen HendersonYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Angela OswaldYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Jo DumvilleYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Matthew LeeYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Thomas PinkneyYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Nikki StubbsYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
Lyn WilsonYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Lower Ground Floor ARRC Building, York, YO10 5DD, UK.
University of York · GB

Funding

Health Technology Assessment Programme 17/42/94Medical Research Council MR/K025643/1Medical Research Council MR/R013748/1
6 · The paper itself

Abstract

backgroundThe majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI.

methodsSWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use. DISCUSSION: Given the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres.

trial registrationISRCTN 26277546 . Prospectively registered on 25 March 2019.

Indexed as

Negative-Pressure Wound TherapySurgical WoundAdultEquivalence Trials as TopicHumansIntentionMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicSurgical Wound InfectionWound HealingNegative pressure wound therapyRandomised controlled trialSecondary intentionSurgical woundsWound healing

Identifiers

PMID34696784
PMCPMC8543414
OpenAlexW3208390876

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.