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Can a simple swab predict surgical wound trouble?

NCT ID NCT06070454

Knowledge-focused Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checks if having a vaginal infection before vulvar surgery raises the risk of wound infections or breakdown. About 91 adults with non-cancerous vulvar conditions will be tested with a swab on surgery day. Researchers will follow up by phone at 1 week and a clinic visit at 4-6 weeks to see how wounds heal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 91 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be 18 years of age * Has histologically confirmed non-malignant vulvar pathology * Is scheduled or planning for WLE/SPV * Signed informed consent obtained prior to any protocol specific procedures Exclusion Criteria: * Unable to give informed consent * 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 malignancy within the last 3 years that required systemic chemotherapy or radiation * Not immunosuppressed or compromised * No active HIV (must have undetectable viral load) * Chronic treatment with corticosteroids 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

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Conditions

The condition(s) this trial relates to.

vaginitis vulvar disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vaginitis Vulvar diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

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