Evidence map›Paper›PMID 29951633›Full record

ArticleBJS open2018

Pilot feasibility randomized clinical trial of negative-pressure wound therapy versus usual care in patients with surgical wounds healing by secondary intention.

C Arundel, C Fairhurst, B Corbacho-Martin, H Buckley, E Clarke, N Cullum, S Dixon, J Dumville, A Firth, E Henderson and 7 more

Abstract read
In one paragraph

Article in BJS open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
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

17 authors.

C ArundelYork Trials Unit, Department of Health Sciences University of York York UK.ORCID 0000-0003-0512-4339
C FairhurstYork Trials Unit, Department of Health Sciences University of York York UK.
B Corbacho-MartinYork Trials Unit, Department of Health Sciences University of York York UK.
H BuckleyYork Trials Unit, Department of Health Sciences University of York York UK.
E ClarkeAcademic Vascular Surgical Unit Hull and East Yorkshire Hospitals NHS Trust Hull UK.
N CullumDivision of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health University of Manchester Manchester UK.
S DixonPatient and Public Involvement Group Hull UK.
J DumvilleDivision of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health University of Manchester Manchester UK.
A FirthAcademic Vascular Surgical Unit Hull and East Yorkshire Hospitals NHS Trust Hull UK.
E HendersonOutpatient Services Hull and East Yorkshire Hospitals NHS Trust Hull UK.
K LambLeeds Wound Research Unit Leeds Community Healthcare NHS Trust Leeds UK.
E McGinnisDepartment for Tissue Viability Leeds Teaching Hospitals NHS Trust Leeds UK.
A OswaldAcademic Vascular Surgical Unit Hull and East Yorkshire Hospitals NHS Trust Hull UK.
P Saramago GoncalvesCentre for Health Economics University of York York UK.
M O SoaresCentre for Health Economics University of York York UK.
N StubbsLeeds Wound Research Unit Leeds Community Healthcare NHS Trust Leeds UK.
I ChetterCentre for Health Economics University of York York UK.

Funding

Department of Health RP-PG-0609-10171
6 · The paper itself

Abstract

backgroundSurgical wounds healing by secondary intention (SWHSI) are increasingly being treated with negative-pressure wound therapy (NPWT) despite a lack of high-quality research evidence regarding its clinical and cost-effectiveness. This pilot feasibility RCT aimed to assess the methods for and feasibility of conducting a future definitive RCT of NPWT for the treatment of SWHSI.

methodsEligible consenting adult patients receiving care at the study sites (2 acute and 1 community) and with a SWHSI appropriate for NPWT or wound dressing treatment were randomized 1 : 1 centrally to receive NPWT or usual care (no NPWT). Participants were followed up every 1-2 weeks for 3 months. Feasibility (recruitment rate, time to intervention delivery) and clinical (time to wound healing) outcomes were assessed.

resultsA total of 248 participants were screened for eligibility; 40 (16·1 per cent) were randomized, 19 to NPWT and 21 to usual care. Twenty-four of the 40 wounds were located on the foot. Participants received NPWT for a median of 18 (range 0-72) days. Two participants in the NPWT group never received the intervention and 14 received NPWT within 48 h of randomization. Five participants in the usual care group received NPWT during the study. Ten of the 40 wounds were deemed to have healed during the study.

conclusionA full-scale RCT to investigate the clinical and cost-effectiveness of NPWT for SWHSI is feasible. This study identified crucial information on recruitment rates and data collection methods to consider during the design of a definitive RCT. Registration number: ISRCTN12761776 (http://www.iscrtn.com).

Identifiers

PMID29951633
PMCPMC5989956

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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.