Dataset Information

Cost-effectiveness of closed incision negative pressure wound therapy in preventing surgical site infection among obese women giving birth by caesarean section: An economic evaluation (DRESSING trial).

ABSTRACT:

Background

There is growing evidence regarding the potential of closed incision negative pressure wound therapy (ci-NPWT) to prevent surgical site infections (SSIs) in healing wounds by primary closure following a caesarean section (CS).

Aim

To assess the cost-effectiveness of ci-NPWT compared to standard dressings for prevention of SSI in obese women giving birth by CS.

Materials and methods

Cost-effectiveness and cost-utility analyses from a health service perspective were undertaken alongside a multicentre pragmatic randomised controlled trial, which recruited women with a pre-pregnancy body mass index ≥30 kg/m² giving birth by elective/semi-urgent CS who received ci-NPWT (n = 1017) or standard dressings (n = 1018). Resource use and health-related quality of life (SF-12v2) collected during admission and for four weeks post-discharge were used to derive costs and quality-adjusted life years (QALYs).

Results

ci-NPWT was associated with AUD$162 (95%CI -$170 to $494) higher cost per person and an additional $12 849 (95%CI -$62 138 to $133 378) per SSI avoided. There was no detectable difference in QALYs between groups; however, there are high levels of uncertainty around both cost and QALY estimates. There is a 20% likelihood that ci-NPWT would be considered cost-effective at a willingness-to-pay threshold of $50 000 per QALY. Per protocol and complete case analyses gave similar results, suggesting that findings are robust to protocol deviators and adjustments for missing data.

Conclusions

ci-NPWT for the prevention of SSI in obese women undergoing CS is unlikely to be cost-effective in terms of health service resources and is currently unjustified for routine use for this purpose.

SUBMITTER: Whitty JA

PROVIDER: S-EPMC10952760 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Cost-effectiveness of closed incision negative pressure wound therapy in preventing surgical site infection among obese women giving birth by caesarean section: An economic evaluation (DRESSING trial).

Whitty Jennifer A JA Wagner Adam P AP Kang Evelyn E Ellwood David D Chaboyer Wendy W Kumar Sailesh S Clifton Vicki L VL Thalib Lukman L Gillespie Brigid M BM

The Australian & New Zealand journal of obstetrics & gynaecology 20230518 5

<h4>Background</h4>There is growing evidence regarding the potential of closed incision negative pressure wound therapy (ci-NPWT) to prevent surgical site infections (SSIs) in healing wounds by primary closure following a caesarean section (CS).<h4>Aim</h4>To assess the cost-effectiveness of ci-NPWT compared to standard dressings for prevention of SSI in obese women giving birth by CS.<h4>Materials and methods</h4>Cost-effectiveness and cost-utility analyses from a health service perspective wer ...[more]

PMID: 37200473

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Project description:ObjectiveTo determine the effectiveness of closed incision negative pressure wound therapy (NPWT) compared with standard dressings in preventing surgical site infection (SSI) in obese women undergoing caesarean section.DesignMulticentre, pragmatic, randomised, controlled, parallel group, superiority trial.SettingFour Australian tertiary hospitals between October 2015 and November 2019.ParticipantsEligible women had a pre-pregnancy body mass index of 30 or greater and gave birth by elective or semi-urgent caesarean section.Intervention2035 consenting women were randomised before the caesarean procedure to closed incision NPWT (n=1017) or standard dressing (n=1018). Allocation was concealed until skin closure.Main outcome measuresThe primary outcome was cumulative incidence of SSI. Secondary outcomes included depth of SSI (superficial, deep, or organ/body space), rates of wound complications (dehiscence, haematoma, seroma, bleeding, bruising), length of stay in hospital, and rates of dressing related adverse events. Women and clinicians were not masked, but the outcome assessors and statistician were blinded to treatment allocation. The pre-specified primary intention to treat analysis was based on a conservative assumption of no SSI for a minority of women (n=28) with missing outcome data. Post hoc sensitivity analyses included best case analysis and complete case analysis.ResultsIn the primary intention to treat analysis, SSI occurred in 75 (7.4%) women treated with closed incision NPWT and in 99 (9.7%) women with a standard dressing (risk ratio 0.76, 95% confidence interval 0.57 to 1.01; P=0.06). Post hoc sensitivity analyses to explore the effect of missing data found the same direction of effect (closed incision NPWT reducing SSI), with statistical significance. Blistering occurred in 40/996 (4.0%) women who received closed incision NPWT and in 23/983 (2.3%) who received the standard dressing (risk ratio 1.72, 1.04 to 2.85; P=0.03).ConclusionProphylactic closed incision NPWT for obese women after caesarean section resulted in a 24% reduction in the risk of SSI (3% reduction in absolute risk) compared with standard dressings. This difference was close to statistical significance, but it likely underestimates the effectiveness of closed incision NPWT in this population. The results of the conservative primary analysis, multivariable adjusted model, and post hoc sensitivity analysis need to be considered alongside the growing body of evidence of the benefit of closed incision NPWT and given the number of obese women undergoing caesarean section globally. The decision to use closed incision NPWT must also be weighed against the increases in skin blistering and economic considerations and should be based on shared decision making with patients.Trial registrationANZCTR identifier 12615000286549.

Project description:IntroductionIn the UK, about a quarter of women give birth by caesarean section (CS) and are offered prophylactic broad-spectrum antibiotics to reduce the risk of maternal postpartum infection. In 2011, national guidance was changed from recommending antibiotics after the umbilical cord was cut to giving antibiotics prior to skin incision based on evidence that earlier administration reduces maternal infectious morbidity. Although antibiotics cross the placenta, there are no known short-term harms to the baby. This study aims to address the research gap on longer term impact of these antibiotics on child health.Methods and analysisA controlled interrupted time series study will use anonymised mother-baby linked routine electronic health records for children born during 2006-2018 recorded in UK primary care (The Health Improvement Network, THIN and Clinical Practice Research Datalink, CPRD) and secondary care (Hospital Episode Statistics, HES) databases. The primary outcomes of interest are asthma and eczema, two common allergy-related diseases in childhood. In-utero exposure to antibiotics immediately prior to CS will be compared with no exposure when given after cord clamping. The risk of outcomes in children delivered by CS will also be compared with a control cohort delivered vaginally to account for time effects. We will use all available data from THIN, CPRD and HES with estimated power of 80% and 90% to detect relative increase in risk of asthma of 16% and 18%, respectively at the 5% significance level.Ethics and disseminationEthical approval has been obtained from the University of Birmingham Ethical Review Committee with scientific approvals obtained from the independent scientific advisory committees from the Medicines and Healthcare products Regulatory Agency for CPRD and the data provider, IQVIA for THIN. The results will be published in peer-reviewed journals, presented at national and international conferences and disseminated to stakeholders.

Dataset Information

Cost-effectiveness of closed incision negative pressure wound therapy in preventing surgical site infection among obese women giving birth by caesarean section: An economic evaluation (DRESSING trial).

Background

Aim

Materials and methods

Results

Conclusions

Publications

Cost-effectiveness of closed incision negative pressure wound therapy in preventing surgical site infection among obese women giving birth by caesarean section: An economic evaluation (DRESSING trial).

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