412: Pilot randomized trial of prophylactic negative pressure wound therapy in obese women after cesarean delivery

Tuuli, Methodius G.; Martin, Shannon; Stout, Molly J.; Steiner, H; Longo, Sherri; Cahill, Alison G.; Tita, Alan; Macones, George A.

doi:10.1016/j.ajog.2016.11.670

Cited by 20 publications

(40 citation statements)

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“…Our results are similar to previous research in this population. 23 26 28 We also found no significant group differences in wound complications in relation to bleeding, dehiscence, haematoma, or seroma.…”

Section: Discussionmentioning

confidence: 46%

Closed incision negative pressure wound therapy versus standard dressings in obese women undergoing caesarean section: multicentre parallel group randomised controlled trial

Gillespie

Webster

Ellwood

et al. 2021

BMJ

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Objective To 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. Design Multicentre, pragmatic, randomised, controlled, parallel group, superiority trial. Setting Four Australian tertiary hospitals between October 2015 and November 2019. Participants Eligible women had a pre-pregnancy body mass index of 30 or greater and gave birth by elective or semi-urgent caesarean section. Intervention 2035 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 measures The 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. Results In 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). Conclusion Prophylactic 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 registration ANZCTR identifier 12615000286549.

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Section: Discussionmentioning

confidence: 46%

Closed incision negative pressure wound therapy versus standard dressings in obese women undergoing caesarean section: multicentre parallel group randomised controlled trial

Gillespie

Webster

Ellwood

et al. 2021

BMJ

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“…Key characteristics for each included study are shown in Table S1 . These studies represent patients from a wide geographical distribution, including five studies from the UK 14 , 15 , 17 , 19 , 20 , two from Ireland 11 , 24 , nine from mainland Europe 10 , 18 , 23 , 25–27 , 30 , 33 , 34 , one from the Nordic region 28 , six from the USA 8 , 16 , 21 , 22 , 31 , 36 , two from Australia 9 , 13 , two from Asia 29 , 32 , and one from Mexico 35 . One additional study was a multicentre study incorporating patients from the USA, France, the Netherlands and South Africa 12 .…”

Section: Resultsmentioning

confidence: 99%

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

Saunders

Nherera²,

Hörner

et al. 2020

BJS Open

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Background 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. Methods 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. Results 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). Conclusion Use of the sNPWT device in patients with risk factors reduced the incidence of SSCs and the mean length of hospital stay.

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“…There are likely numerous reasons for these differences in outcomes of studies comprised in meta-analysis 2 (MLA versus control), including variances in wound type, bioburden levels, device negative pressure settings, and definitions of SSI. Different outcomes between Tuuli et al 26 and Chaboyer et al 22 studies, which evaluated ciNPT compared with standard incision care for obese women undergoing elective c-section, may be explained by different definitions of obesity. The Tuuli et al 26 study included only obese patients with BMI ≥30 kg/m 2 , whereas Chaboyer et al 22 defined obesity as BMI ≥25 kg/m 2 , which could somewhat account for differences in outcomes between the two studies in meta-analysis 2.…”

Section: Discussionmentioning

confidence: 93%

“…Different outcomes between Tuuli et al 26 and Chaboyer et al 22 studies, which evaluated ciNPT compared with standard incision care for obese women undergoing elective c-section, may be explained by different definitions of obesity. The Tuuli et al 26 study included only obese patients with BMI ≥30 kg/m 2 , whereas Chaboyer et al 22 defined obesity as BMI ≥25 kg/m 2 , which could somewhat account for differences in outcomes between the two studies in meta-analysis 2. For further comparison, in meta-analysis 1, Gunatilake et al 13 defined obesity as BMI ≥35 kg/m 2 and Ruhstaller et al 20 defined obesity as BMI ≥30 kg/m 2 .…”

Section: Discussionmentioning

confidence: 93%

“…The outcomes of each of the studies within the MLA group of studies are also more variable than FOAM study outcomes. Of the MLA studies, one study shows a statistically significant difference 28 and one study shows a marginally significant difference favoring MLA versus control, 25 whereas 2 studies (Tuuli et al 26 and Uchino et al 27 ) show a higher rate of SSIs in the MLA group and the remaining 4 studies show a slightly lower rate of SSIs in the MLA group. All of the 9 FOAM studies favor FOAM versus control, 4 of which were statistically significant or marginally significant.…”

Section: Discussionmentioning

confidence: 97%

See 1 more Smart Citation

Meta-analysis Comparing Outcomes of Two Different Negative Pressure Therapy Systems in Closed Incision Management

Singh

Gabriel²,

Silverman³

et al. 2019

Plastic and Reconstructive Surgery - Global Open

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412: Pilot randomized trial of prophylactic negative pressure wound therapy in obese women after cesarean delivery

Cited by 20 publications

References 0 publications

Closed incision negative pressure wound therapy versus standard dressings in obese women undergoing caesarean section: multicentre parallel group randomised controlled trial

Closed incision negative pressure wound therapy versus standard dressings in obese women undergoing caesarean section: multicentre parallel group randomised controlled trial

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

Meta-analysis Comparing Outcomes of Two Different Negative Pressure Therapy Systems in Closed Incision Management

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