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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Vaginitis panel

    Diagnostic test

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

Treatment groups

91 Participants
are divided into 1 treatment group
Group A: Positive Perioperative VaginitisExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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