A Phase 3 interventional study of Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. in Pelvic Organ Prolapse, Urinary Incontinence and Pelvic Floor Disorders, sponsored by University of New Mexico. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by University of New Mexico · Phase 3, Interventional, and Treatment
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.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 137 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
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Exclusion Criteria:
Chlorhexidine gluconate 2% 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.
Povidone iodine 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.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Rate of Urinary Tract Infection
Urinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms.
Time frame: 2 weeks post operatively
Rate of Surgical Site Infection
Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
Time frame: 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))
Time frame: Post operative day 1
| Milestone | Chlorhexidine Gluconate | Povidone Iodine |
|---|---|---|
| Started | 72 | 65 |
| Completed | 61 | 58 |
| Not completed | 11 | 7 |
Urinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms.
| Participants | Chlorhexidine Gluconate | Povidone Iodine |
|---|---|---|
| Rate of Urinary Tract Infection | 4 | 7 |
Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
| Participants | Chlorhexidine Gluconate | Povidone Iodine |
|---|---|---|
| Rate of Surgical Site Infection | 1 | 2 |
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))
| Participants | Chlorhexidine Gluconate | Povidone Iodine |
|---|---|---|
| Vaginal irritation - 0 | 50 | 50 |
| Vaginal irritation - 1 | 1 | 0 |
| Vaginal irritation - 2 | 1 | 0 |
| Vaginal irritation - 3 | 0 | 2 |
| Vaginal irritation - 4 or 5 | 2 | 2 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chlorhexidine Gluconate | 0/61 (0%) | 4/61 (6.6%) | 0/61 (0%) |
| Povidone Iodine | 0/58 (0%) | 4/58 (6.9%) | 0/58 (0%) |
| Event | Chlorhexidine Gluconate | Povidone Iodine |
|---|---|---|
| Surgical Site InfectionInfections and infestations | 1/61 | 2/58 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 0/61 | 1/58 |
| Suture reactionSkin and subcutaneous tissue disorders | 0/61 | 1/58 |
| Skin irritationSkin and subcutaneous tissue disorders | 1/61 | 0/58 |
| Bacterial VaginosisInfections and infestations | 1/61 | 0/58 |
| Urethral injuryRenal and urinary disorders | 1/61 | 0/58 |
| Age, Continuous(years) | Chlorhexidine Gluconate | Povidone Iodine | Total |
|---|---|---|---|
| Mean | 58 ± 13 | 57 ± 12 | 57.5 ± 12.5 |
| Sex: Female, Male(Participants) | Chlorhexidine Gluconate | Povidone Iodine | Total |
|---|---|---|---|
| Female | 61 | 58 | 119 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Chlorhexidine Gluconate | Povidone Iodine | Total |
|---|---|---|---|
| African American | 0 | 2 | 2 |
| White | 30 | 20 | 50 |
| Latinx | 26 | 25 | 51 |
| American Indian | 5 | 12 | 17 |
| Other | 2 | 4 | 6 |
| Region of Enrollment(participants) | Chlorhexidine Gluconate | Povidone Iodine | Total |
|---|---|---|---|
| United States | 61 | 58 | 119 |
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University of New Mexico