Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Povidone Iodine) | Active Comparator | Patients to receive povidone iodine for the surgical preparation of the vagina. |
|
| Intervention (4% Chlorhexidine gluconate) | Experimental | Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine | Drug | Patients will receive povidone iodine for the surgical preparation of the vagina. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of surgery to 24-48 hours after surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Magdy Milad, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prentice Women's Hospital - Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
Not provided
| Label | URL |
|---|---|
| ACOG Solutions for the Surgical Preparation of the Vagina | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control (Povidone Iodine) | Patients to receive povidone iodine for the surgical preparation of the vagina. Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina. |
| FG001 | Intervention (4% Chlorhexidine Gluconate) | Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control (Povidone Iodine) | Patients to receive povidone iodine for the surgical preparation of the vagina. Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina. |
| BG001 | Intervention (4% Chlorhexidine Gluconate) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 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. | Number of participants in control and active groups | Posted | Count of Participants | Participants | Day of surgery to 24-48 hours after surgery |
|
Data were collected for each patient immediately postoperatively to 24-48 hours postoperatively.
The survey of vaginal & urinary symptoms used in this study was designed using the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) created by the NIH & NCI 7. The language & format of the PTO-CTCAE questions have been cognitively tested. Questions on vaginal burning and itching were investigator-developed items using similar language as the PRO-CTCAE, since these adverse events were not contained in the PRO-CTCAE item library.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (Povidone Iodine) | Patients to receive povidone iodine for the surgical preparation of the vagina. Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment | Genitourinary - One patient in the chlorhexidine group reported severe vulvar swelling that resolved within 24-48 hours after exposure |
Single-blinded design. Present study included participants undergoing hysteroscopic procedures these procedures themselves may certainly influence postoperative irritative symptoms. Loss of follow-up both immediately and 24-48 hours postoperative.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Supriya Rastogi | Northwestern University Feinberg School of Medicine | supriya.rastogi@northwestern.e | supriya.rastogi@northwestern.edu |
Not provided
| 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 | May 9, 2018 | Apr 11, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
Not provided
Not provided
Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
Not provided
Not provided
Patients will be randomized to the control or intervention and not be told which antiseptic they received for the surgical preparation of the vagina.
| 4% Chlorhexidine Gluconate | Drug | Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. |
|
Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. |
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Intervention (4% Chlorhexidine Gluconate) | Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. 4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina. | 0 | 60 | 0 | 60 | 1 | 59 |
|
Not provided
Not provided
Not provided
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |