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Single-use negative-pressure wound therapy versus conventional dressings for closed surgical incisions: systematic literature review and meta-analysis.

ABSTRACT: Surgical-site complications (SSCs) remain a significant cause of morbidity and mortality, particularly in high-risk patients. The aim of this study was to determine whether prophylactic use of a specific single-use negative-pressure wound therapy (sNPWT) device reduced the incidence of SSCs after closed surgical incisions compared with conventional dressings. A systematic literature review was performed using MEDLINE, Embase and the Cochrane Library to identify articles published from January 2011 to August 2018. RCTs and observational studies comparing PICO™ sNPWT with conventional dressings, with at least 10 patients in each treatment arm, were included. Meta-analyses were performed to determine odds ratios (ORs) or mean differences (MDs), as appropriate. PRISMA guidelines were followed. The primary outcome was surgical-site infection (SSI). Secondary outcomes were other SSCs and hospital efficiencies. Risk of bias was assessed. Of 6197 citations screened, 29 studies enrolling 5614 patients were included in the review; all studies included patients with risk factors for SSCs. sNPWT reduced the number of SSIs (OR 0.37, 95 per cent c.i. 0.28 to 0.50; number needed to treat (NNT) 20). sNPWT reduced the odds of wound dehiscence (OR 0.70, 0.53 to 0.92; NNT 26), seroma (OR 0.23, 0.11 to 0.45; NNT 13) and necrosis (OR 0.11, 0.03 to 0.39; NNT 12). Mean length of hospital stay was shorter in patients who underwent sNPWT (MD -1.75, 95 per cent c.i. -2.69 to -0.81). Use of the sNPWT device in patients with risk factors reduced the incidence of SSCs and the mean length of hospital stay.

SUBMITTER: Saunders C

PROVIDER: S-EPMC7893467 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:AimsThe primary objective of this study was to compare the postoperative infection rate between negative pressure wound therapy (NPWT) and conventional dressings for closed incisions following soft-tissue sarcoma (STS) surgery. Secondary objectives were to compare rates of adverse wound events and functional scores.MethodsIn this prospective, single-centre, randomized controlled trial (RCT), patients were randomized to either NPWT or conventional sterile occlusive dressings. A total of 17 patients, with a mean age of 54 years (21 to 81), were successfully recruited and none were lost to follow-up. Wound reviews were undertaken to identify any surgical site infection (SSI) or adverse wound events within 30 days. The Toronto Extremity Salvage Score (TESS) and Musculoskeletal Tumor Society (MSTS) score were recorded as patient-reported outcome measures (PROMs).ResultsThere were two out of seven patients in the control group (28.6%), and two out of ten patients in the intervention group (20%) who were diagnosed with a SSI (p > 0.999), while one additional adverse wound event was identified in the control group (p = 0.593). No significant differences in PROMs were identified between the groups at either 30 days (TESS, p = 0.987; MSTS, p = 0.951) or six-month (TESS, p = 0.400) follow-up. However, neoadjuvant radiotherapy was significantly associated with a SSI within 30 days of surgery, across all patients (p = 0.029). The mean preoperative modified Glasgow Prognostic Score (mGPS) was also significantly higher among patients who developed a postoperative adverse wound event (p = 0.028), including a SSI (p = 0.008), across both groups.ConclusionThis is the first RCT comparing NPWT with conventional dressings following musculoskeletal tumour surgery. Postoperative wound complications are common in this group of patients and we observed an overall SSI rate of 23.5%. We propose proceeding to a multicentre trial, which will help more clearly define the role of closed incision NPWT in STS surgery. Cite this article: Bone Jt Open 2021;2(12):1049-1056.

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:ImportanceSurgical site infections (SSIs) are common after laparotomy wounds and are associated with a significant economic burden. The use of negative pressure wound therapy (NPWT) has recently been broadened to closed surgical incisions.ObjectiveTo evaluate the association of prophylactic NPWT with SSI rates in closed laparotomy incisions performed for general and colorectal surgery in elective and emergency settings.Data sourcesThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and Google Scholar databases were searched without language restrictions for relevant articles from inception until December 2017. The latest search was performed on December 31, 2017. The bibliographies of retrieved studies were further screened for potential additional studies.Study selectionRandomized clinical trials and nonrandomized studies were included. Unpublished reports were excluded, as were studies that examined NPWT (or standard nonpressure) dressings only without a comparator group. Studies that evaluated the use of NPWT in open abdominal incisions were also excluded. Disagreement was resolved by discussion, and if the question remained unsettled, the opinion of the senior author was sought. A total of 198 citations were identified, and 189 were excluded.Data extraction and synthesisThis meta-analysis was conducted according to PRISMA guidelines. Data were independently extracted by 2 authors. A random-effects model was used for statistical analysis.Main outcomes and measuresThe primary outcome measure was SSI, and secondary outcomes included seroma and wound dehiscence rates. These outcomes were chosen before data collection.ResultsNine unique studies (3 randomized trials and 2 prospective and 4 retrospective studies) capturing 1266 unique patients were included. Of these, 1187 patients with 1189 incisions were included in the final analysis (52.3% male among 7 studies reporting data on sex; mean [SD] age, 52 [15] years among 8 studies reporting data on age). Significant clinical and methodologic heterogeneity existed among studies. On random-effects analysis, NPWT was associated with a significantly lower rate of SSI compared with standard dressings (pooled odds ratio [OR], 0.25; 95% CI, 0.12-0.52; P < .001). However, no difference in rates of seroma (pooled OR, 0.38; 95% CI, 0.12-1.23; P = .11) or wound dehiscence (pooled OR, 2.03; 95% CI, 0.61-6.78; P = .25) was found. On sensitivity analysis, focusing solely on colorectal procedures, NPWT significantly reduced SSI rates (pooled OR, 0.16; 95% CI, 0.07-0.36; P < .001).Conclusions and relevanceApplication of NPWT on closed laparotomy wounds in general and colorectal surgery is associated with reduced SSI rates but similar rates of seroma and wound dehiscence compared with conventional nonpressure dressings.

Project description:IntroductionPatients with closed high-energy injuries associated with major trauma have surprisingly high rates of surgical site infection in incisions created during fracture fixation. One factor that may reduce the risk of surgical site infection is the type of dressing applied over the closed surgical incision. In this multicentre randomised clinical trial, negative-pressure wound therapy will be compared with standard dressings with outcomes of deep infection, quality of life, pain and disability.Methods and analysisAdult patients presenting to hospital within 72?hours of sustaining major trauma, requiring a surgical incision to treat a fractured lower limb, are eligible for inclusion. Randomisation, stratified by trial centre, open/closed fracture at presentation and Injury Severity Score (ISS) ?15?versus ISS ?16?will be administered via a secure web-based service using minimisation. The random allocation will be to either standard wound management or negative-pressure wound therapy.Trial participants will usually have clinical follow-up at the local fracture clinic for a minimum of 6 months, as per standard National Health Service practice. Diagnosis of deep infection will be recorded at 30 days. Functional, pain and quality of life outcome data will be collected using the Disability Rating Index, Douleur Neuropathique Questionnaire and Euroqol - 5 Dimension - 5 level (EQ-5D-5L) questionnaires at 3 months and 6 months postinjury. Further data will be captured on resource use and any late postoperative complications.Longer term outcomes will be assessed annually for 5?years and reported separately.Ethics and disseminationNational Research Ethics Committee approved this study on 16 February 2016 16/WM/0006.The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of this trial. The results of this trial will inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury.Trial registration numberISRCTN12702354; Pre-results.

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Single-use negative-pressure wound therapy versus conventional dressings for closed surgical incisions: systematic literature review and meta-analysis.

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