Evidence map›Paper›PMID 30066454›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2019

Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial.

N Hyldig, C A Vinter, M Kruse, O Mogensen, C Bille, J A Sorensen, R F Lamont, C Wu, L N Heidemann, M H Ibsen and 5 more

2 registry-linked trialsOpen access · bronzeAbstract readPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 40 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 11 pooled it
12.5field-weighted citation impact, top 1% 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.

NCT04434820 nacompletednot on this mapstarted 2020, after this paper: background citation

External Negative Pressure Dressing System (ENPDS) vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.

TypeinterventionalSponsorAin Shams Maternity HospitalRan2020 to 2021Enrolled260ConditionsWound DehiscenceArmsExternal negative pressure dressing system (Yuwell 7E-A portable suction unit)
NCT05266053 nacompletednot on this mapstarted 2022, after this paper: background citation

Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections

TypeinterventionalSponsorIndiana UniversityRan2022 to 2023Enrolled24ConditionsHypertrophic Skin Condition of Anterior AbdomenArmsPICO 7 dressing, Standard wound dressing
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 11 syntheses or guidelines pooled it, 95 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 6 institutions in 3 countries.

N HyldigDepartment of Plastic Surgery, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
C A VinterDepartment of Gynaecology and Obstetrics, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
M KruseDanish Centre for Health Economics (DaCHE), Institute of Public Health, University of Southern Denmark, Odense, Denmark.
O MogensenDepartment of Pelvic Cancer, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.
C BilleDepartment of Plastic Surgery, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
J A SorensenDepartment of Plastic Surgery, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
R F LamontDepartment of Gynaecology and Obstetrics, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
C WuDepartment of Gynaecology and Obstetrics, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
L N HeidemannDepartment of Plastic Surgery, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
M H IbsenDepartment of Gynaecology and Obstetrics, Hospital of Southern Jutland, Esbjerg, Denmark.
J B LaursenDepartment of Gynaecology and Obstetrics, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.
P G OvesenDepartment of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby, Aarhus, Denmark.
C RorbyeDepartment of Gynaecology and Obstetrics, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.
M TanvigDepartment of Gynaecology and Obstetrics, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
J S JoergensenDepartment of Gynaecology and Obstetrics, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
Odense University Hospital · DKUniversity of Southern Denmark · DKUniversity of Copenhagen · DKAarhus University Hospital · DKHospital South West Jutland · DKKarolinska University Hospital · SE

Funding

Odense University HospitalRegion of Southern DenmarkUniversity of Southern Denmark
6 · The paper itself

Abstract

objectiveTo evaluate the reduction of surgical site infections by prophylactic incisional negative pressure wound therapy compared with standard postoperative dressings in obese women giving birth by caesarean section.

designMulticentre randomised controlled trial.

settingFive hospitals in Denmark. POPULATION: Obese women (prepregnancy body mass index (BMI) ≥30 kg/m

methodThe participants were randomly assigned to incisional negative pressure wound therapy or a standard dressing after caesarean section and analysed by intention-to-treat. Blinding was not possible due to the nature of the intervention.

main outcome measuresThe primary outcome was surgical site infection requiring antibiotic treatment within the first 30 days after surgery. Secondary outcomes included wound exudate, dehiscence and health-related quality of life.

resultsIncisional negative pressure wound therapy was applied to 432 women and 444 women had a standard dressing. Demographics were similar between groups. Surgical site infection occurred in 20 (4.6%) women treated with incisional negative pressure wound therapy and in 41 (9.2%) women treated with a standard dressing (relative risk 0.50, 95% CI 0.30-0.84; number needed to treat 22; P = 0.007). The effect remained statistically significant when adjusted for BMI and other potential risk factors. Incisional negative pressure wound therapy significantly reduced wound exudate whereas no difference was found for dehiscence and quality of life between the two groups.

conclusionProphylactic use of incisional negative pressure wound therapy reduced the risk of surgical site infection in obese women giving birth by caesarean section. TWEETABLE ABSTRACT: RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI.

Indexed as

AdultBandagesCesarean SectionDenmarkFemaleHumansNegative-Pressure Wound TherapyObesityPregnancyPregnancy ComplicationsRisk FactorsStandard of CareSurgical Wound InfectionTreatment OutcomeWound HealingCaesarean sectionincisional negative pressure wound therapyobesitysurgical site infection

Identifiers

PMID30066454
PMCPMC6586160
OpenAlexW2885884611

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.