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Am J Perinatol 2024; 41(05): 523-530
DOI: 10.1055/a-2217-8556
SMFM Fellowship Series Article

Preoperative Application of Chlorhexidine to Reduce Infection with Cesarean Delivery after Labor (PRACTICAL): A Randomized Clinical Trial

Chelsea A. DeBolt 
1   Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York
,
Manasa G. Rao 
1   Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York
,
Leslie Warren
1   Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York
,
Shaelyn Johnson
1   Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York
,
Patricia Rekawek 
2   Department of Obstetrics and Gynecology, NYU Langone Health, NYU Langone Hospital Long Island, NYU Long Island School of Medicine, Mineola, New York
,
Elianna Kaplowitz 
3   Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York
,
Jessica Overbey
3   Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York
,
Keisha Paul
1   Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York
,
Nicola Tavella
1   Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York
,
Johanna Monro
1   Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York
,
Joanne Stone
1   Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York
,
Angela Bianco
1   Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York
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Abstract

Objective To evaluate whether use of both preoperative 2% chlorhexidine gluconate abdominal cloth and 4% chlorhexidine gluconate vaginal scrub is effective in reducing surgical site infections (SSIs) in patients undergoing cesarean delivery after labor.

Study Design This is a single-center, randomized clinical trial in which patients were randomized 1:1 to receive 2% chlorhexidine gluconate cloth applied to the abdomen in addition to the application of 4% chlorhexidine gluconate vaginal scrub versus standard of care. The primary outcome was rate of SSIs, including endometritis, by 6 weeks postdelivery. The secondary outcomes were other wound complications (erythema at the operative site, skin separation, drainage, fever, hematoma, seroma) by 6 weeks postdelivery, hospital readmission for wound complications, and day of discharge after cesarean delivery.

Results A total of 319 patients between September 2018 and February 2021 met eligibility criteria: 160 were randomized to the chlorhexidine gluconate abdominal cloth and vaginal scrub group and 159 were randomized to the standard of care group. The groups did not have significant differences in maternal demographic characteristics. Of the 302 (95%) individuals included in primary analysis, there was no statistically significant difference in SSI and endometritis rate by 6 weeks postdelivery (6.6% in chlorhexidine vs. 5.3% standard of care, p = 0.65). Secondary outcomes were also similar among the two groups.

Conclusion The combination of preoperative 2% chlorhexidine gluconate abdominal cloth and 4% chlorhexidine gluconate vaginal scrub does not appear to reduce the risk of SSI with cesarean delivery after trial of labor when compared with standard of care.

Key Points

  • Preoperative chlorhexidine abdominal cloth/vaginal scrub does not decrease SSI in cesarean after labor.

  • Preoperative chlorhexidine abdominal cloth/vaginal scrub does not decrease other wound complications in cesarean after labor.

  • There was no difference in discharge day, 2-week or 6-week SSI rates.

Keywords

antibiotics - cesarean delivery - chlorhexidine - labor - surgical site infection - wound infections

Note

ClinicalTrials.gov identifier NCT03423147.




Publication History

Received: 23 August 2023

Accepted: 22 November 2023

Accepted Manuscript online:
25 November 2023

Article published online:
31 December 2023

© 2023. Thieme. All rights reserved.

Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA

 

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