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RecruitingNCT06070454Updated Oct 20, 2025

Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions

An interventional study of Vaginitis panel in Vaginitis and Vulvar Diseases, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-20.

Sponsored by University of Virginia · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Primary:

  • To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
  • To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.
Read the detailed description

Primary:

  • To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
  • To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.
02

Conditions studied

  • Vaginitis
  • Vulvar Diseases
03

In context

Vaginitis

98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.

This study's planned enrollment of 91 is below the median of 108 across 71 interventional studies indexed under Vaginitis.

Browse Vaginitis studies →

Lead sponsor

University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.

Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be 18 years of age
  • Has confirmed non-malignant vulvar pathology
  • Is scheduled or planning for WLE/SPV
  • Signed obtained prior to any protocol specific procedures

Exclusion criteria

Exclusion Criteria:

  • Unable to give
  • Women who are pregnant or nursing (lactating) women at time of consent
  • No prior RT
  • No recent antibiotic use within the last 3 weeks or 5.5 times the half-life of the antibiotic (whichever is shorter)
  • No history of prior within the last 3 years that required systemic chemotherapy or radiation
  • Not or compromised
  • No active (must have undetectable viral load)
  • Chronic treatment with or other immunosuppressive agents including topical corticosteroids in the pelvis. Inhaled corticosteroids are allowed
  • No active uncontrolled severe infections (not responding to antibiotics), except acute or chronic pelvic inflammatory disease
  • Uncontrolled diabetes mellitus
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
91 participants (estimated)

Study arms

  • Experimental
    Positive Perioperative Vaginitis

    Participants who test positive for BV, candida, and/or trichomonas on perioperative vaginitis swab.

    Diagnostic Test: Vaginitis panel

Interventions

  • Diagnostic testVaginitis panel

    vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida

06

What researchers measure

Primary outcomes

  1. the rate of perioperative vulvovaginitis

    To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision

    Time frame: 8 weeks

  2. rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown

    To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Jun 2026, 25 months after the start.

Of 22 interventional studies with no phase under Vaginitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 25 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2023
First posted
Oct 6, 2023
StartActual
Apr 25, 2024
Primary completionEst.
Jun 1, 2026
CompletionEst.
Aug 1, 2026
Last update
Oct 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06070454
Responsible party
Carrie Sopata (Associate Professor, University of Virginia) — Principal investigator
First posted
Oct 6, 2023
Start date
Apr 25, 2024
Primary completion
Jun 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Oct 20, 2025

Study contacts

Amanda Urban
Contact
AJR5Y@uvahealth.org
434.409.3100

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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