Vaginal Preparation Prior to Hysterectomy

• Sponsor: TriHealth Inc. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03412734
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.4
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hysterectomy	Drug: Chlorhexidine; Drug: Iodine	Phase 4

Detailed Description

Postoperative infection remains the most common complication of surgical procedures in gynecology. Historically, 30-40% of patients undergoing a hysterectomy develop a post-operative infection. The initiation of antibiotic prophylaxis for appropriate surgical procedures was a significant advancement in the prevention of surgical site infection.

Antibiotic prophylaxis has been standardized and universally implemented. A remaining variable is the method of aseptic preparation of the vagina with substantial variation of technique being reported even within institutions.

The most recent Committee Opinion by the American College of Obstetricians and Gynecologists concludes there is insufficient evidence to render a strong recommendation for either povidone-iodine or chlorhexidine as the ideal agent for surgical preparation of the vagina and that further evidence is necessary.

Povidone-iodine solution has been considered the standard for aseptic surgical preparation of the vagina for decades and is the only solution approved by the FDA for vaginal use. There are however specific qualities of the solution that suggest it may be less than ideal for use in the vagina. More contemporary efforts have begun to focus on chlorhexidine as a more ideal agent for aseptic efforts in surgical preparation of the vagina.

The purpose of our study is to use a randomized controlled trial to determine if chlorhexidine gluconate surgical preparation maintains a lower rate of contamination to the surgical field.

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Is Chlorhexidine Vaginal Preparation Prior to Hysterectomy Superior to Iodine in Reducing Bacterial Count; a Randomized Controlled Trial
• Actual Study Start Date: May 18, 2018
• Actual Primary Completion Date: Aug 26, 2019
• Actual Study Completion Date: Jan 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chlorhexidine group	Drug: Chlorhexidine; Chlorhexidine preparation solutions
Active Comparator: Iodine group	Drug: Iodine; Iodine-based preparation solutions

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Contamination [90 minutes from initial preparation]

   Contamination is defined as having >5000 bacteria within a culture

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Undergoing total vaginal, laparoscopic assisted vaginal, total laparoscopic, or robotic-assisted laparoscopic hysterectomy by a physician at Cincinnati Urogynecology Associates or Tri-State Gynecology Oncology TriHealth Inc.

• Concomitant procedures such as vaginal vault suspension, suburethral sling, cystoscopy, enterocele repair, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy, staging procedures, lymph node sampling and other indicated procedures will be included

• English speaking

• Ability to provide consent

Exclusion Criteria:

• Unwillingness to participate in the study

• Non English speaking

• Patients that do not undergo a hysterectomy

• Reported allergy to iodine or chlorhexidine preparation solutions

• Patients undergoing planned debulking surgery for ovarian, fallopian tube or primary peritoneal cancers

• Current infection necessitating hysterectomy

• Active sepsis, pelvic abscess or pelvic inflammatory disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220

Sponsors and Collaborators

• TriHealth Inc.

Investigators

• Principal Investigator: Catrina Crisp, MD, TriHealth - Cincinnati Urogynecology Associates

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 20, 2020

More Information

Publications

None provided.

• Responsible Party: TriHealth Inc.
• ClinicalTrials.gov Identifier: NCT03412734
• Other Study ID Numbers: 17-102
• First Posted: Jan 26, 2018
• Last Update Posted: Jan 11, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chlorhexidine

Study Results

Participant Flow

Pre-assignment Detail	6 patients were excluded (3 - not randomized at the day of surgery; 3 - missing study consent).

Arm/Group Title	Chlorhexidine Group	Iodine Group
Arm/Group Description	Patients randomized to the Chlorhexidine group will undergo pre-surgical vaginal aseptic preparation using 4% Chlorhexidine preparation solutions.	Those patients randomized to the povidone-iodine group will have their pre-surgical vaginal aseptic preparation performed using 10% povidone-iodine solution.
Period Title: Overall Study
STARTED	47	41
COMPLETED	44	41
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Chlorhexidine Group	Iodine Group	Total
Arm/Group Description	Chlorhexidine: Chlorhexidine preparation solutions	Iodine: Iodine-based preparation solutions	Total of all reporting groups
Overall Participants	44	41	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.6 (10.9)	62.2 (11.6)	59.8 (11.4)
Sex: Female, Male (Count of Participants)
Female	44 100%	41 100%	85 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	42 95.5%	39 95.1%	81 95.3%
Black/African American	2 4.5%	1 2.4%	3 3.5%
Asian	0 0%	1 2.4%	1 1.2%
Region of Enrollment (Count of Participants)
United States	44 100%	41 100%	85 100%
Bacterial Vaginosis (BV) positive (Count of Participants)
Count of Participants [Participants]	12 27.3%	18 43.9%	30 35.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Contamination
Description	Contamination is defined as having >5000 bacteria within a culture
Time Frame	90 minutes from initial preparation

Outcome Measure Data

Analysis Population Description

Use participants with cultures at 90 minutes

Arm/Group Title	Chlorhexidine Group	Iodine Group
Arm/Group Description	Chlorhexidine: Chlorhexidine preparation solutions	Iodine: Iodine-based preparation solutions
Measure Participants	42	41
Count of Participants [Participants]	20 45.5%	35 85.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chlorhexidine Group, Iodine Group
	Comments	We hypothesized that chlorhexidine would have a lower bacterial count compared to iodine. Our sample size was calculated to be 71 patients per arm to detect a 22% difference in cultures defined as contaminated at 90 minutes from surgical preparation.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is adjusted for baseline BV (Bacterial Vaginosis)
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	10.6
	Confidence Interval	(2-Sided) 95%; 3.02 to 37.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	2 week post-op
Arm/Group Title	Chlorhexidine Group		Iodine Group
Arm/Group Description	Chlorhexidine: Chlorhexidine preparation solutions		Iodine: Iodine-based preparation solutions
All Cause Mortality
	Chlorhexidine Group		Iodine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/41 (0%)
Serious Adverse Events
	Chlorhexidine Group		Iodine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Chlorhexidine Group		Iodine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.