Surgical Preparation of the VaginaPhase 4NCT03305159
Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution
A Phase 4 study testing Povidone-Iodine and 4% Chlorhexidine Gluconate in people with Surgical Preparation of the Vagina, run by Northwestern University at 1 site in United States.
Trial summary
Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4% isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical preparations of the vagina. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Preparation of the Vagina
- What is being tested?
- Povidone-Iodine and 4% Chlorhexidine Gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 15 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing hysteroscopy
- Gynecologic dilation \& curettage
- Endometrial ablation
- Essure without concomitant laparoscopy
Who cannot join
- Pregnant
- Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or anaphylaxis to chlorhexidine gluconate or povidone iodine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prentice Women's Hospital - Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Tolerance of Chlorhexidine Gluconate Versus Povidone Iodine Vaginal Cleansing Solution: a Randomized Control Trial
Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4% isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical preparations of the vagina. Patients will be randomized to either control (povidone iodine) or experimental (chlorhexidine gluconate), and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.
Read the detailed description
Surgical site antisepsis is critical in preventing surgical site infections. Although chlorhexidine gluconate has proven to be superior to povidone iodine for surgical site antisepsis, povidone iodine is the only FDA-approved antiseptic solution for surgical preparation of the vagina. Many surgeons are hesitant to use chlorhexidine gluconate for preoperative vaginal cleansing due to the alcohol dissolvent present in the solutions that is implicated in a greater risk of irritation. Yet, there has been no randomized study to illustrate whether the risk of vaginal irritation is greater in chlorhexidine gluconate versus povidone iodine. Thus, the purpose of the study is to conduct a randomized control trial to compare the tolerance of 4% chlorhexidine gluconate to povidone iodine using patient-reported outcomes of vaginal or urinary symptoms. Patients will be randomized to either control or experimental, and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.
- Conditions
- Surgical Preparation of the Vagina
- Being tested
- Povidone-Iodine, 4% Chlorhexidine Gluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Patients will receive povidone iodine for the surgical preparation of the vagina.
4% Chlorhexidine GluconateDrug
Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
| Study group | Role | What they receive |
|---|---|---|
| Control (Povidone Iodine) | Active comparator | Patients to receive povidone iodine for the surgical preparation of the vagina. Receives: Drug: Povidone-Iodine |
| Intervention (4% Chlorhexidine gluconate) | Experimental | Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. Receives: Drug: 4% Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.
Measured: Day of surgery to 24-48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 Aug 2017
- Primary completion1 Apr 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Preparation of the VaginaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Milad, MD, Northwestern University
- Investigators
- Magdy Milad, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305159
- Sponsor's protocol ID
- STU00204759
- Status last verified
- Jun 2019
- First submitted
- 4 Sep 2017
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Chlorhexidine Gluconate Versus Povidone Iodine Vaginal Cleansing Solution: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03305159
- Acronym / sponsor ID
- STU00204759
- Conditions
- Surgical Preparation of the Vagina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Posted 27 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4% isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical preparations of the vagina. Patients will be randomized to either control (povidone iodine) or experimental (chlorhexidine gluconate), and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.
Detailed description
Surgical site antisepsis is critical in preventing surgical site infections. Although chlorhexidine gluconate has proven to be superior to povidone iodine for surgical site antisepsis, povidone iodine is the only FDA-approved antiseptic solution for surgical preparation of the vagina. Many surgeons are hesitant to use chlorhexidine gluconate for preoperative vaginal cleansing due to the alcohol dissolvent present in the solutions that is implicated in a greater risk of irritation. Yet, there has been no randomized study to illustrate whether the risk of vaginal irritation is greater in chlorhexidine gluconate versus povidone iodine. Thus, the purpose of the study is to conduct a randomized control trial to compare the tolerance of 4% chlorhexidine gluconate to povidone iodine using patient-reported outcomes of vaginal or urinary symptoms. Patients will be randomized to either control or experimental, and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
| Arm | Type | Receives |
|---|---|---|
| Control (Povidone Iodine) | Active comparator | Drug: Povidone-IodinePatients to receive povidone iodine for the surgical preparation of the vagina. |
| Intervention (4% Chlorhexidine gluconate) | Experimental | Drug: 4% Chlorhexidine GluconatePatients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing hysteroscopy
- Gynecologic dilation \& curettage
- Endometrial ablation
- Essure without concomitant laparoscopy
Key exclusion criteria (2 listed)
- Pregnant
- Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or anaphylaxis to chlorhexidine gluconate or povidone iodine.
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 |
|---|---|---|
| Povidone-IodinePatients will receive povidone iodine for the surgical preparation of the vagina. | Drug | Control (Povidone Iodine) |
| 4% Chlorhexidine GluconatePatients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. | Drug | Intervention (4% Chlorhexidine gluconate) |
Primary outcome
Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
Time frame: Day of surgery to 24-48 hours after surgery
To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ACOG Solutions for the Surgical Preparation of the VaginaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Recruiting
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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.
Magdy Milad, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone-Iodine and 4% Chlorhexidine Gluconate in people with Surgical Preparation of the Vagina, run by Northwestern University at 1 site in United States.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) (time frame: Day of surgery to 24-48 hours after surgery). 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 27 Jun 2019.