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

Primary Purpose

Vaginitis, Vulvar Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vaginitis panel
Sponsored by
University of Virginia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Vaginitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
September 29, 2023
Last Updated
September 29, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT06070454
Brief Title
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Official Title
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 14, 2023 (Anticipated)
Primary Completion Date
November 14, 2025 (Anticipated)
Study Completion Date
November 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginitis, Vulvar Diseases

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
vaginitis panel
Intervention Description
vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida
Primary Outcome Measure Information:
Title
the rate of perioperative vulvovaginitis
Description
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
Title
rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Lacy
Phone
4342430126
Email
rmc9p@hscmail.mcc.virginia.edu
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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