Preventative Laparoscopic HysterectomyNCT05692986
Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy
A study testing A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed. in people with Preventative Laparoscopic Hysterectomy, run by Henry Ford Health System.
Trial summary
This is a randomized control trial which will randomize patients who will be undergoing laparoscopic (conventional or robotic assisted) total hysterectomy to vaginal prep with 4% chlorhexidine gluconate vs 10% povidone iodine. There is paucity of information regarding the superiority of one over the other. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preventative Laparoscopic Hysterectomy
- What is being tested?
- A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who are scheduled for total laparoscopic hysterectomy
Who cannot join
- not able to consent in English or have allergy to the 10% povidone betadine or 4% chlorhexidine solution.
About this study
Official title: Randomized Control Trial: Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy
This is a randomized control trial which will randomize patients who will be undergoing laparoscopic (conventional or robotic assisted) total hysterectomy to vaginal prep with 4% chlorhexidine gluconate vs 10% povidone iodine. There is paucity of information regarding the superiority of one over the other.
Read the detailed description
This is a randomized control trial. During surgery, preoperative vaginal prep is routinely done for hysterectomies. This can be completed with 10% povidone iodine or with 4% chlorhexidine preparation. This study will investigate whether the routine use of betadine vaginal prep in comparison to chlorhexidine prep is superior. Patients will be informed of the study at the time of their preoperative visit in the gynecology clinic at time of surgical scheduling. The attached informed consent sheet will be given to the patient for their signature. The patients will be randomized to receive either 10% povidone iodine or with 4% chlorhexidine vaginal preparation solution. This is not anticipated to take extra time or resources in the operating room setting because the surgical vaginal preparation solutions are typically readily available in the operating room setting. The patients will be assigned an envelope when they are in clinic after they have signed the consent form and that will be the group they are randomized to.
Once the patients are randomized, it is anticipated that 50 patients will be enrolled in each study arm. Following randomization patients will receive the vaginal preparation per the randomization assignment. The patient will be blinded to the study arm. The provider will not be blinded. Follow-up will occur on postoperative day #1 by phone call, and at the 2-week and 6-week follow-up visits.
- Conditions
- Preventative Laparoscopic Hysterectomy
- Being tested
- A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed.
- Keywords
- 4% chlorhexidine, 10% povidone iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed.Diagnostic test
This is a randomized control trial that will compare chlorhexidine vaginal prep with iodine vaginal prep. Our primary outcome will be assessed using a vaginal swab test to look for aerobic and anaerobic cultures. Positive cultures will be defined as colony forming count of >5000cfu. All patients will receive preoperative antibiotics. Patients will receive a vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery was completed.
| Study group | Role | What they receive |
|---|---|---|
| povidone betadine | Active comparator | Not described Receives: Diagnostic Test: A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed. |
| chlorhexidine | Active comparator | Not described Receives: Diagnostic Test: A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of positive cultures in each arm will be compared.
The number of positive cultures in each arm will be assessed using vaginal swabs to look for contaminated specimens. Positive cultures will be defined as colony forming counts of >5000cfu, and these will be compared in each arm to determine which preparation is more effective
Measured: before antibiotic administration, 30 minutes after vaginal prep and q1hr thereafter until the surgery was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Feb 2022 (estimated)
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: Did not move forward due to staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventative Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joelle Abood, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692986
- Sponsor's protocol ID
- 15037
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial: Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT05692986
- Acronym / sponsor ID
- 15037
- Conditions
- Preventative Laparoscopic Hysterectomy
- Keywords
- 4% chlorhexidine, 10% povidone iodine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not move forward due to staffing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial which will randomize patients who will be undergoing laparoscopic (conventional or robotic assisted) total hysterectomy to vaginal prep with 4% chlorhexidine gluconate vs 10% povidone iodine. There is paucity of information regarding the superiority of one over the other.
Detailed description
This is a randomized control trial. During surgery, preoperative vaginal prep is routinely done for hysterectomies. This can be completed with 10% povidone iodine or with 4% chlorhexidine preparation. This study will investigate whether the routine use of betadine vaginal prep in comparison to chlorhexidine prep is superior. Patients will be informed of the study at the time of their preoperative visit in the gynecology clinic at time of surgical scheduling. The attached informed consent sheet will be given to the patient for their signature. The patients will be randomized to receive either 10% povidone iodine or with 4% chlorhexidine vaginal preparation solution. This is not anticipated to take extra time or resources in the operating room setting because the surgical vaginal preparation solutions are typically readily available in the operating room setting. The patients will be assigned an envelope when they are in clinic after they have signed the consent form and that will be the group they are randomized to.
Once the patients are randomized, it is anticipated that 50 patients will be enrolled in each study arm. Following randomization patients will receive the vaginal preparation per the randomization assignment. The patient will be blinded to the study arm. The provider will not be blinded. Follow-up will occur on postoperative day #1 by phone call, and at the 2-week and 6-week follow-up visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| povidone betadine | Active comparator | Diagnostic Test: A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed. |
| chlorhexidine | Active comparator | Diagnostic Test: A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are scheduled for total laparoscopic hysterectomy
Key exclusion criteria (1 listed)
- not able to consent in English or have allergy to the 10% povidone betadine or 4% chlorhexidine solution.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed.This is a randomized control trial that will compare chlorhexidine vaginal prep with iodine vaginal prep. Our primary outcome will be assessed using a vaginal swab test to look for aerobic and anaerobic cultures. Positive cultures will be defined as colony forming count of >5000cfu. All patients will receive preoperative antibiotics. Patients will receive a vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery was completed. | Diagnostic test | chlorhexidine, povidone betadine |
Primary outcome
The number of positive cultures in each arm will be compared.
Time frame: before antibiotic administration, 30 minutes after vaginal prep and q1hr thereafter until the surgery was completed
The number of positive cultures in each arm will be assessed using vaginal swabs to look for contaminated specimens. Positive cultures will be defined as colony forming counts of >5000cfu, and these will be compared in each arm to determine which preparation is more effective
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing A vaginal swab for aerobic and anaerobic cultures before antibiotic administration, 30 minutes after vaginal prep and every hour thereafter until the surgery is completed. in people with Preventative Laparoscopic Hysterectomy, run by Henry Ford Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of positive cultures in each arm will be compared. (time frame: before antibiotic administration, 30 minutes after vaginal prep and q1hr thereafter until the surgery was completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.