Vaginal Preparation Prior to Hysterectomy

Summary

This is a randomized controlled trial to determine the influence of chlorhexidine gluconate surgical/topical antiseptic solutions on the bacterial environment of the vagina during hysterectomy and compare that to the effect of standard iodine-based preparations on the same.

Timeline

Start

2018-05-18

Primary completion

2019-08-26

Completion

2020-01-29

Outcome

Met primary endpoint

Stopped (Enrollment): “The institutional review board recommended the study stop enrollment prior to achieving its initial sample size for patient safety.”

paper Chlorhexidine demonstrated a lower percentage of positive cultures at 90 minutes (47.6% vs 85.4%; odds ratio, 10.6; P = 0.001). PMID 34333502 ↗

Publications

• Results Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol. 1991 Feb;29(2):297-301. doi: 10.1128/jcm.29.2.297-301.1991.
• Hill AM, Pauls RN, Basil J, Tam T, Yook E, Shatkin-Margolis A, Kleeman S, Yeung J, Aldrich E, Crisp CC. Chlorhexidine Versus Iodine for Vaginal Preparation Before Hysterectomy: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):77-84. doi: 10.1097/SPV.0000000000001066.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Chlorhexidine	Small molecule	4 %	Topical
Comparator	Iodine	Other / unclassified	10 %	Topical

Indications

No indication recorded.