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

Objective To evaluate the reduction of surgical site infections by prophylactic incisional negative pressure wound therapy compared with standard postoperative dressings in obese women giving birth by caesarean section. Design Multicentre randomised controlled trial. Setting Five hospitals in Denmar...

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Published in:	BJOG : an international journal of obstetrics and gynaecology Vol. 126; no. 5; pp. 628 - 635
Main Authors:	Hyldig, N, Vinter, CA, Kruse, M, Mogensen, O, Bille, C, Sorensen, JA, Lamont, RF, Wu, C, Heidemann, LN, Ibsen, MH, Laursen, JB, Ovesen, PG, Rorbye, C, Tanvig, M, Joergensen, JS
Format:	Journal Article
Language:	English
Published:	England Wiley Subscription Services, Inc 01-04-2019 John Wiley and Sons Inc
Subjects:	Adult Antibiotics Bandages - statistics & numerical data Birth Body mass index Caesarean section Cesarean section Cesarean Section - adverse effects Clinical trials Dehiscence Demography Denmark Dressings Evidence-based medicine Female General Obstetrics Humans incisional negative pressure wound therapy Infections Medicin och hälsovetenskap Negative-Pressure Wound Therapy - methods Obesity Obesity - complications Obesity - surgery Pregnancy Pregnancy Complications - surgery Pressure Quality of life Risk Factors Standard of Care - statistics & numerical data Statistical analysis Surgery surgical site infection Surgical site infections Surgical Wound Infection - etiology Surgical Wound Infection - prevention & control Treatment Outcome Womens health Wound Healing Wounds Denmark Caesarean section incisional negative pressure wound therapy obesity surgical site infection
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Summary:	Objective To evaluate the reduction of surgical site infections by prophylactic incisional negative pressure wound therapy compared with standard postoperative dressings in obese women giving birth by caesarean section. Design Multicentre randomised controlled trial. Setting Five hospitals in Denmark. Population Obese women (prepregnancy body mass index (BMI) ≥30 kg/m2) undergoing elective or emergency caesarean section. Method The participants were randomly assigned to incisional negative pressure wound therapy or a standard dressing after caesarean section and analysed by intention‐to‐treat. Blinding was not possible due to the nature of the intervention. Main outcome measures The primary outcome was surgical site infection requiring antibiotic treatment within the first 30 days after surgery. Secondary outcomes included wound exudate, dehiscence and health‐related quality of life. Results Incisional negative pressure wound therapy was applied to 432 women and 444 women had a standard dressing. Demographics were similar between groups. Surgical site infection occurred in 20 (4.6%) women treated with incisional negative pressure wound therapy and in 41 (9.2%) women treated with a standard dressing (relative risk 0.50, 95% CI 0.30–0.84; number needed to treat 22; P = 0.007). The effect remained statistically significant when adjusted for BMI and other potential risk factors. Incisional negative pressure wound therapy significantly reduced wound exudate whereas no difference was found for dehiscence and quality of life between the two groups. Conclusion Prophylactic use of incisional negative pressure wound therapy reduced the risk of surgical site infection in obese women giving birth by caesarean section. Tweetable RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI. Tweetable RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI.
Bibliography:	This article is commented on by M Tuuli, p. 635 in this issue. To view this mini commentary visit This article has journal club questions by BD Einerson, p. 636 in this issue. To view these visit Linked article https://doi.org/10.1111/1471-0528.15572 . https://doi.org/10.1111/1471-0528.15610 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Linked article This article is commented on by M Tuuli, p. 635 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471-0528.15572. Trial registration: ClinicalTrials.gov (NCT 01890720) This article has journal club questions by BD Einerson, p. 636 in this issue. To view these visit https://doi.org/10.1111/1471-0528.15610.
ISSN:	1470-0328 1471-0528 1471-0528
DOI:	10.1111/1471-0528.15413