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The institutional review board recommended the study stop enrollment prior to achieving its initial sample size for patient safety.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine group | Experimental |
| |
| Iodine group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug | Chlorhexidine preparation solutions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Contamination | Contamination is defined as having >5000 bacteria within a culture | 90 minutes from initial preparation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catrina Crisp, MD | TriHealth - Cincinnati Urogynecology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1706728 | Result | 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. | |
| 34333502 | Derived | 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. |
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6 patients were excluded (3 - not randomized at the day of surgery; 3 - missing study consent).
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine Group | Patients randomized to the Chlorhexidine group will undergo pre-surgical vaginal aseptic preparation using 4% Chlorhexidine preparation solutions. |
| FG001 | Iodine Group | Those patients randomized to the povidone-iodine group will have their pre-surgical vaginal aseptic preparation performed using 10% povidone-iodine solution. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine Group | Chlorhexidine: Chlorhexidine preparation solutions |
| BG001 | Iodine Group | Iodine: Iodine-based preparation solutions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Contamination | Contamination is defined as having >5000 bacteria within a culture | Use participants with cultures at 90 minutes | Posted | Count of Participants | Participants | 90 minutes from initial preparation |
|
2 week post-op
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlorhexidine Group | Chlorhexidine: Chlorhexidine preparation solutions | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catrina Crisp, MD MSc | TriHealth Inc. | 513-463-4300 | Catrina_Crisp@trihealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 | Oct 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D007455 | Iodine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D006219 |
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| Iodine |
| Drug |
Iodine-based preparation solutions |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Bacterial Vaginosis (BV) positive | Bacterial Vaginosis was identified through a modified Nugent method (Nugent RP et al. 1991), and Nugent score points was awarded based on three morphotypes: medium to large gram positive rods, small gram negative or variable rods, curved gram negative or variable rods. Each of these morphotypes was assigned a score based on their initial count, and the three morphotypes is then added, and any score >7 is consistent bacterial vaginosis, and a score <3 is normal flora. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Iodine Group | Iodine: Iodine-based preparation solutions | 0 | 41 | 0 | 41 | 0 | 41 |
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| Halogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |