Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis

Summary

Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.

Timeline

Start

2014-03

Primary completion

2016-07

Completion

2016-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Chlorhexidine - Isopropyl Alcohol vs Povidone-Iodine Scrub and Paint; p = 0.38; Risk Ratio (RR) 0.90; Fisher Exact; NCT02202577 ↗

paper Preoperative antiseptic skin preparation with chlorhexidine-alcohol 26-mL single-step applicator before cesarean did not result in less frequent surgical site infection PMID 28599898 ↗

Publications

• Background Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
• Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5.
• Springel EH, Wang XY, Sarfoh VM, Stetzer BP, Weight SA, Mercer BM. A randomized open-label controlled trial of chlorhexidine-alcohol vs povidone-iodine for cesarean antisepsis: the CAPICA trial. Am J Obstet Gynecol. 2017 Oct;217(4):463.e1-463.e8. doi: 10.1016/j.ajog.2017.05.060. Epub 2017 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Chlorhexidine	Small molecule	—	Topical
Subject	Isopropyl alcohol	Other / unclassified	—	Topical
Subject	Povidone-Iodine	Other / unclassified	—	Topical

Indications

No indication recorded.