Evidence map›Paper›PMID 31932387›Full record

Trial reportBMJ open2020

Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds.

Jane Blazeby, Bluebelle Study Group

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 28% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. A network meta-analysis of the timing of wound dressing removal.Annals of the Royal College of Surgeons of England · 2025
    Pooled it
  2. Article
  3. 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

2 authors at 1 institution in 1 country.

Jane BlazebyDepartment of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK j.m.blazeby@bristol.ac.uk.
Bluebelle Study Group
University of Bristol · GB

Funding

Department of Health DRF-2011-04-016Department of Health NIHR300175Medical Research Council MR/K025643/1Medical Research Council MR/S001751/1
6 · The paper itself

Abstract

objectiveSurgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle study assessed the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds.

designA pilot, factorial RCT.

settingFive UK hospitals.

participantsAdults undergoing abdominal surgery with a primary surgical wound.

interventionsParticipants were randomised to 'simple dressing', 'glue-as-a-dressing' or 'no dressing', and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure). PRIMARY AND SECONDARY OUTCOME MEASURES: Feasibility outcomes focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L).

resultsBetween March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133, glue=129 and 'no dressing'=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132), respectively. Adherence to disclosure time was 99% and 86% before and after wound closure, respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks.

conclusionsA definitive RCT of dressing strategies including 'no dressing' is feasible. Further work is needed to optimise questionnaire response rates. TRIAL REGISTRATION NUMBER: 49328913; Pre-results.

Indexed as

Practice Guidelines as TopicQuality of LifeWound HealingAdultAgedBandagesCost-Benefit AnalysisFeasibility StudiesFemaleHumansIncidenceMaleMiddle AgedPilot ProjectsSurgical Wound InfectionUnited Kingdompilot studyrandomised controlled trialsurgical site infectiontissue adhesive as a dressingwound dressing

Identifiers

PMID31932387
PMCPMC7045119
OpenAlexW2991100252

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.