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Is prophylactic negative pressure wound therapy initiated immediately after repair of the surgical incision effective in reducing surgical-site infection after cesarean delivery in obese women?
In this randomized clinical trial that included 1608 obese women, there was no significant difference in the risk of surgical-site infection after cesarean delivery with prophylactic negative pressure wound therapy (3.6%) vs standard wound dressing (3.4%).
These findings do not support routine use of prophylactic negative pressure wound therapy in obese women after cesarean delivery.
Obesity increases the risk of both cesarean delivery and surgical-site infection. Despite widespread use, it is unclear whether prophylactic negative pressure wound therapy reduces surgical-site infection after cesarean delivery in obese women.
To evaluate whether prophylactic negative pressure wound therapy, initiated immediately after cesarean delivery, lowers the risk of surgical-site infections compared with standard wound dressing in obese women.
Design, Setting, and Participants
Multicenter randomized trial conducted from February 8, 2017, through November 13, 2019, at 4 academic and 2 community hospitals across the United States. Obese women undergoing planned or unplanned cesarean delivery were eligible. The study was terminated after 1624 of 2850 participants were recruited when a planned interim analysis showed increased adverse events in the negative pressure group and futility for the primary outcome. Final follow-up was December 18, 2019.
Participants were randomly assigned to either undergo prophylactic negative pressure wound therapy, with application of the negative pressure device immediately after repair of the surgical incision (n = 816), or receive standard wound dressing (n = 808).
Main Outcomes and Measures
The primary outcome was superficial or deep surgical-site infection according to the Centers for Disease Control and Prevention definitions. Secondary outcomes included other wound complications, composite of surgical-site infections and other wound complications, and adverse skin reactions.
Of the 1624 women randomized (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed the study: 806 in the negative pressure group (median duration of negative pressure, 4 days) and 802 in the standard dressing group. Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, −1.46% to 2.19%, P = .70). Of 30 prespecified secondary end points, 25 showed no significant differences, including other wound complications (2.6% vs 3.1%; difference, −0.53%; 95% CI, −1.93% to 0.88%; P = .46) and composite of surgical-site infections and other wound complications (6.5% vs 6.7%; difference, −0.27%; 95% CI, −2.71% to 2.25%; P = .83). Adverse skin reactions were significantly more frequent in the negative pressure group (7.0% vs 0.6%; difference, 6.95%; 95% CI, 1.86% to 12.03%; P < .001).
Conclusions and Relevance
Among obese women undergoing cesarean delivery, prophylactic negative pressure wound therapy, compared with standard wound dressing, did not significantly reduce the risk of surgical-site infection. These findings do not support routine use of prophylactic negative pressure wound therapy in obese women after cesarean delivery.
ClinicalTrials.gov Identifier: NCT03009110
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Corresponding Author: Methodius Tuuli, MD, MPH, MBA, Department of Obstetrics and Gynecology, Indiana University School of Medicine, 550 N University Blvd, UH 2440, Indianapolis, IN 46202 (email@example.com).
Accepted for Publication: July 7, 2020.
Author Contributions: Drs Tuuli and Liu had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Tuuli, Liu, Tita, Trudell, Carter, Caughey, Warren, Colditz, Macones, Harper.
Acquisition, analysis, or interpretation of data: Tuuli, Liu, Tita, Longo, Trudell, Shanks, Woolfolk, Caughey, Warren, Odibo, Colditz, Macones, Harper.
Drafting of the manuscript: Tuuli, Liu, Shanks, Woolfolk, Harper.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Liu, Woolfolk, Colditz.
Obtained funding: Tuuli, Liu, Macones, Harper.
Administrative, technical, or material support: Tuuli, Tita, Longo, Trudell, Carter, Shanks, Colditz, Macones.
Supervision: Tuuli, Tita, Shanks, Odibo, Macones.
Conflict of Interest Disclosures: Dr Tuuli reported receiving grants from the National Institutes of Health (NIH) and Acelity. Dr Liu reported receiving grants from the NIH. Dr Tita reported receiving grants from National Institute of Child Health and Human Development (NICHD). Dr Warren reported receiving grants from the NIH; personal fees from CareFusion/BD, PDI Inc, Pursuit Vascular Inc, and Homburg & Partner. Dr Colditz reported receiving grants from the NIH and grants and nonfinancial support from Acelity. Dr Harper reported receiving grants from the NICHD and nonfinancial support from Acelity. No other disclosures were reported.
Funding/Support: The study was funded by grant R01HD086007 from the Eunice Kennedy Shriver NICHD (Drs Tuuli and Harper). In addition, Acelity donated negative pressure devices and provided supplemental funding.
Role of the Funder/Sponsor: The NIH and Acelity had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Specifically, the funders had no right to veto publication or to control the decision regarding to which journal the manuscript was submitted.
Disclaimer: The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official view of the NIH or Acelity.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank the participants in this trial. We also thank the following individuals who received compensation for their contributions: Data and safety monitoring board members: Sindhu Srinivas, MD, MSCE; Alison Cahill, MD, MSCI; and Jenifer Allsworth, PhD; Indiana University: Shannon Barnes, MBA; and Maureen Mullen, BSN; Washington University in St Louis: Shannon Martin, RN; Monica Anderson, BSN; and Tracy Burger, BSN; University of Alabama at Birmingham: Rachel LeDuke, MSN; and Nancy Saxon, RN; Mercy Hospital St Louis: Mary Wilcox, BSN; Ochsner Baptist Medical Center: Christine Servay, CCRC; Kate Garvey, MS; JoEllen Johnson, MSHCM; and Melissa Hendricks, RN.
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