Vaginal Preparation Prior to Hysterectomy
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|ClinicalTrials.gov Identifier: NCT03412734|
Recruitment Status : Terminated (The institutional review board recommended the study stop enrollment prior to achieving its initial sample size for patient safety.)
First Posted : January 26, 2018
Results First Posted : November 18, 2020
Last Update Posted : January 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hysterectomy||Drug: Chlorhexidine Drug: Iodine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||August 26, 2019|
|Actual Study Completion Date :||January 29, 2020|
|Experimental: Chlorhexidine group||
Chlorhexidine preparation solutions
|Active Comparator: Iodine group||
Iodine-based preparation solutions
- Number of Participants With Contamination [ Time Frame: 90 minutes from initial preparation ]Contamination is defined as having >5000 bacteria within a culture
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412734
|United States, Ohio|
|Good Samaritan Hospital|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Catrina Crisp, MD||TriHealth - Cincinnati Urogynecology Associates|