Abstract
Purpose
To compare the rates of wound-related complications among women undergoing a cesarean section when the surgical team used intra-operative glove changing versus usual care.
Methods
All women undergoing a cesarean section at a single, county hospital were randomized to usual care or intra-operative glove changing prior to abdominal closure. Participants were randomized at the time of decision for cesarean section; surgeons were not blinded to the randomization arm. The primary outcome was any wound-related complication, including wound hematoma, seroma, skin separation of at least 1 cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery. To detect a reduction in the primary outcome from 17% in the control group to 9% in the intervention group with 80% power, a total of 554 women (277 per group) were required. Secondary outcomes included other infectious complications including endometritis and other superficial or deep soft tissue infections.
Results
From August 2015 to November 2016, 277 women were randomized to usual care and 276 women were randomized to intra-operative glove changing. The two groups were well balanced in terms of demographic data, comorbid conditions and surgical characteristics. Intra-operative glove changing led to a significant decrease in composite wound complications from 13.6% in the control group to 6.4% in the intervention group (p = 0.008).
Conclusion
Intra-operative glove changing prior to abdominal closure during cesarean section significantly reduced the incidence of post-operative wound complications.
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Acknowledgements
We thank Janette Strathy, M.D., for the original concept of the study.
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JS, M.D.: protocol/project development, data collection and manuscript writing. BR, M.D.: protocol/project development, clinical supervision and manuscript editing. CR, M.D.: manuscript writing. RV, Ph.D.: Protocol/project development, data analysis and manuscript editing.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
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We declare that we have no conflict of interest.
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Scrafford, J.D., Reddy, B., Rivard, C. et al. Effect of intra-operative glove changing during cesarean section on post-operative complications: a randomized controlled trial. Arch Gynecol Obstet 297, 1449–1454 (2018). https://doi.org/10.1007/s00404-018-4748-y
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DOI: https://doi.org/10.1007/s00404-018-4748-y