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
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine gluconate | Experimental | Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
|
| Povidone Iodine | Active Comparator | Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. | Drug | Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Urinary Tract Infection | Urinary tract infection as defined by positive urine culture of >10,000 cfu, or empirically treated symptoms. | 2 weeks post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Surgical Site Infection | Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf | 14 days postoperatively |
| Vaginal Irritation | Vaginal irritation (including specific symptoms of discomfort, burning, or itching) based on a 5-point scale (Likert type, from 0 minimum/better to 5 maximum/worse, total score reported)) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen Taylor, BA | University of New Mexico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34973179 | Derived | Rockefeller NF, Petersen TR, Komesu YM, Meriwether K, Dunivan G, Ninivaggio C, Jeppson PC. Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. Am J Obstet Gynecol. 2022 Jul;227(1):66.e1-66.e9. doi: 10.1016/j.ajog.2021.12.260. Epub 2021 Dec 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine Gluconate | Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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 | Oct 22, 2020 |
Not provided
Not provided
Not provided
Not provided
Participants will be anesthetized during the intervention and will not be informed of the arm of their randomization
| Post operative day 1 |
| Povidone Iodine |
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine Gluconate | Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
| BG001 | Povidone Iodine | Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Rate of Urinary Tract Infection | Urinary tract infection as defined by positive urine culture of >10,000 cfu, or empirically treated symptoms. | Posted | Count of Participants | Participants | 2 weeks post operatively |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Rate of Surgical Site Infection | Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf | Posted | Count of Participants | Participants | 14 days postoperatively |
|
| |||||||||||||||||||||||||||||||
| Secondary | Vaginal Irritation | Vaginal irritation (including specific symptoms of discomfort, burning, or itching) based on a 5-point scale (Likert type, from 0 minimum/better to 5 maximum/worse, total score reported)) | Posted | Count of Participants | Participants | Post operative day 1 |
|
|
6 weeks
Not provided
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 | Chlorhexidine Gluconate | Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. | 0 | 61 | 4 | 61 | 0 | 61 |
| EG001 | Povidone Iodine | Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. | 0 | 58 | 4 | 58 | 0 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Site Infection | Infections and infestations | SSI | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Bronchitis | Systematic Assessment | Bronchitis |
|
| Suture reaction | Skin and subcutaneous tissue disorders | Suture reaction | Systematic Assessment | suture abscess |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Vuvlar irritation | Systematic Assessment | self-limited delayed vulvar skin irritation 72 hours after surgery |
|
| Bacterial Vaginosis | Infections and infestations | BV | Systematic Assessment | BV |
|
| Urethral injury | Renal and urinary disorders | Urethral injury | Systematic Assessment | urethral injury at the time of aborted midurethral sling placement. |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Jeppson, site contact for study | University of New Mexico | 505-967-8428 | pjeppson@salud.unm.edu |
| Jun 20, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2020 | Jun 20, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014549 | Urinary Incontinence |
| D059952 | Pelvic Floor Disorders |
| D005831 | Genital Diseases, Female |
| D013530 | Surgical Wound Infection |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D011248 | Pregnancy Complications |
| D000091662 | Genital Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| Male |
|
| White |
|
| Latinx |
|
| American Indian |
|
| Other |
|
|
|