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

Hyldig, Nana; Vinter, Christina Anne; Kruse, Marie; Mogensen, Ole; Bille, Camilla; Sørensen, Jesper Roed; Lamont, Ronnie; Wu, Chunsen; Heidemann, LN; Ibsen, MH; Laursen, J. B.; Ovesen, P.; Rørbye, Christina; Tanvig, Mette; Joergensen, Jan Stener

doi:10.1111/1471-0528.15413

Cited by 76 publications

(104 citation statements)

References 33 publications

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“…[11][12][13] We recently carried out a multicentre randomised controlled trial (RCT) that evaluated the effectiveness of prophylactic iNPWT in obese women (body mass index; BMI ≥30kg/m 2 ) delivering by caesarean section. 14 This study demonstrated that prophylactic iNPWT statistically significantly halved the risk of SSI compared with standard postoperative dressings after CS (RR 0.50, 95% CI 0.30-0.84; P=0.007). Some decision-analytic modelling studies of iNPWT used on abdominal surgical incisions suggests that iNPWT may lower hospital or healthcare costs in obese patients at high risk of SSI.…”

Section: Introductionmentioning

confidence: 66%

“…Details of the RCT have been reported elsewhere. 14 In brief, the trial was performed in two tertiary, and three teaching hospitals in Denmark from 2013 to 2016. Overall, 876 women with a pre-pregnancy BMI of ≥30 kg/m 2 who had an emergency or planned CS were randomised to iNPWT (n=432) or a standard postoperative dressing (n=444) and followed for 30 days post-CS.…”

Section: Methodsmentioning

confidence: 99%

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Cost‐effectiveness of incisional negative pressure wound therapy compared with standard care after caesarean section in obese women: a trial‐based economic evaluation

Joergensen

Bille

et al. 2018

BJOG

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To evaluate the cost-effectiveness of incisional Negative Pressure Wound Therapy (iNPWT) in preventing surgical site infection in obese women after caesarean section DESIGN A cost-effectiveness analysis conducted alongside a clinical trial SETTING Five obstetric departments in Denmark POPULATION Women with a pre-gestational body mass index ≥30 kg/m 2 METHOD We used data from a randomised controlled trial of 876 obese women who underwent elective or emergency caesarean section and were subsequently treated with iNPWT (n=432) or a standard dressing (n=444). Costs were estimated using data from four Danish National Databases and analysed from a healthcare perspective with a time horizon of three months after birth. MAIN OUTCOME MEASURES Cost effectiveness based on incremental cost per surgical site infection avoided and per qualityadjusted life year (QALY) gained. RESULTS The total health care costs per woman were 5,793.60 for iNPWT and 5,840.89 for standard dressings. Incisional NPWT was the dominant strategy because it was both less expensive and more effective, however, no statistical significant difference was found for costs or QALYs. At a willingness to pay threshold of 30,000, the probability of the intervention being cost-effective was 92.8 percent. A subgroup analysis stratifying by BMI shows that the cost saving of the intervention was mainly driven by the benefit to patients with a pre-pregnancy BMI ≥35 kg/m 2. CONCLUSION Incisional NPWT appears to be cost saving compared to standard dressings but this finding is not statistically significant. The cost savings were primarily found in patients with a pre-pregnancy BMI ≥35 kg/m2. FUNDING No funding was obtained for this economic evaluation. The randomised controlled trial (RCT) was funded by grants from the

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Section: Introductionmentioning

confidence: 66%

Section: Methodsmentioning

confidence: 99%

Cost‐effectiveness of incisional negative pressure wound therapy compared with standard care after caesarean section in obese women: a trial‐based economic evaluation

Joergensen

Bille

et al. 2018

BJOG

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“…More recently, the indications for NPWT have expanded to include the management of high-output exudate and seromas by employing it as an alternative method to closed suction draining. 8 In our unit, a modified two-layer negative pressure wound therapy (2-LNPWT) dressing in combination with a standard negative pressure dressing system [Renasys Go, Smith & Nephew, UK] has routinely been employed as a standard of care to manage inguinal lymphadenectomy wounds postoperatively by the senior author (MM). The rationale for employing the 2-LNPWT technique is that it acts as a traditional closed-suction drainage (CSD) system whilst simultaneously applying continuous external compression to the skin and the wound cavity deep to it.…”

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confidence: 99%

Improved Perioperative Seroma and Complication Rates Following the Application of a 2-Layer Negative Pressure Wound Therapy System After Inguinal Lymphadenectomy for Metastatic Cutaneous Melanoma

et al. 2020

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Background. Perioperative complications following inguinal lymphadenectomy, including seroma formation, are frequent. We have employed a 2-layer negative pressure wound therapy (2-LNPWT) as a method to reduce seroma rate and perioperative complications. We present the outcome of our initial experience with 2-LNPWT and compare the outcomes of its use with traditional closed suction drains (CSDs). Materials and methods. A non-randomised retrospective case-control series was analysed. Surgeons performing inguinal lymphadenectomy for metastatic cutaneous melanoma utilised either the 2-LNPWT therapy or traditional CSDs according to their practice preference. Results. The study included 111 patients. The cohorts were well matched for gender, disease burden, body mass index and comorbidities. The 2-LNPWT technique was associated with significantly better postoperative outcomes than CSD, in terms of incidence of seroma formation (26.9% vs 49.4%; p \ 0.03), period of drainage (15 days vs 20 days; p = 0.005) and return to theatre rate (0% vs 15.3%; p = 0.03). The overall seroma rate was 44.1%. The only significant association with seroma initiation was the type of drainage system used (2-LNPWT 31.2% vs CSD 58.3%; p \ 0.03; OR 3.0). The method of drainage did not alter the course of an established seroma. There was no significant difference in overall or disease-specific survival detected between the 2 groups. Conclusion. This retrospective non-randomised case control study has demonstrated the safe use of a novel application of negative pressure wound therapy that significantly reduced the incidence of seroma formation and postoperative complication rate for inguinal lymphadenectomy for melanoma.

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“…However, the results of randomized controlled trials have been mixed. A randomized trial of iNPWT in obese patients undergoing cesarean reported a reduction in SSI rates [23]. Another randomized trial of elective and urgent general surgery patients showed lower rates of SSI with iNPWT, but patients with dirty wounds, BMI > 40, and ASA > III were excluded [24].…”

Section: Discussionmentioning

confidence: 99%

A Multi-Modal Approach to Closing Exploratory Laparotomies Including High-Risk Wounds

Andrade

Guerra

Punch

2020

Cureus

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Background Laparotomy incisions with contamination have a high incidence of surgical site infection (SSI). One strategy to reduce SSI has been to allow these wounds to heal by secondary intention; however, this results in an ongoing need for wound care after discharge. Methods A prospectively maintained Acute and Critical Care Surgery database was queried for patients who underwent exploratory laparotomy during 2008-2018. Patients were stratified into two groups: 2008-2015 (no protocol [NP]) and 2016-2018 (closure protocol [CP]). CP patients were operated on by a single surgeon utilizing a multi-modal high-risk incisional closure protocol, which included dilute chlorhexidine lavage, closed suction drains for incisions deeper than 3 centimeters, and incisional negative-pressure wound therapy (iNPWT). The CDC (Centers for Disease Control and Prevention) guidelines were used to determine wound classification and SSI based on chart review. Groups were compared using univariate and multivariate analysis. Results A total of 139 patients met the study criteria. The overall SSI rate, including superficial and deep space infections, was no different in NP versus CP (21.6 vs. 24.1%; p=0.74). The rate of superficial SSI was similar between NP and CP (11.8 vs. 8.4%; p=0.53). Rates of wound closure at discharge were higher in the CP group than the NP group across wound classes, with the greatest difference among dirty wounds (50.0% NP vs. 94.9% CP; p<0.01). CP significantly increased the likelihood of wound closure (OR=179.2; p<0.001) even after controlling for body mass index, wound classification, ASA (American Society of Anesthesiologists) status, and initially open abdomen. Conclusions By addressing both tissue factors and bacterial burden through the use of a multi-modal high-risk incisional closure protocol involving iNPWT, all wounds can be considered for closure without increasing the risk of SSI.

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

Abstract: RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI.

Cited by 76 publications

References 33 publications

Cost‐effectiveness of incisional negative pressure wound therapy compared with standard care after caesarean section in obese women: a trial‐based economic evaluation

Cost‐effectiveness of incisional negative pressure wound therapy compared with standard care after caesarean section in obese women: a trial‐based economic evaluation

Improved Perioperative Seroma and Complication Rates Following the Application of a 2-Layer Negative Pressure Wound Therapy System After Inguinal Lymphadenectomy for Metastatic Cutaneous Melanoma

A Multi-Modal Approach to Closing Exploratory Laparotomies Including High-Risk Wounds

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