Benign Vulvar Lesion Clinical Trial
Official title:
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
| Verified date | October 2022 |
| Source | Washington University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | November 23, 2021 |
| Est. primary completion date | November 23, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - All women, >=18 undergoing vulvar surgery - Biopsy proven benign or premalignant lesion requiring surgical management. - Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery. - Scheduled to undergo surgical management for their vulvar disease supervised by a faculty member within the Division of OBGYN at Washington University School of Medicine - Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: - Women who are pregnant - Women scheduled to undergo a radical vulvectomy - Women scheduled to undergo a concomitant graft, flap or plastic surgery - Women <18 years of age - History of prior vulvar radiation - Inability to sign an informed consent form prior to registration on study - Inability to understand spoken or written English - Prisoner |
| Country | Name | City | State |
|---|---|---|---|
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Washington University School of Medicine |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vulvar Wound Complications Compared Between the Two Arms | Wound complication will be defined as a composite outcome that includes wound breakdown, sterile site infection, hematoma, seroma diagnosed within 30 days after excision. Sterile Site Infection (SSI) - defined as purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection. | Within 30 days of surgery (estimated to be 30 days) | |
| Secondary | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Clinical risk factors could include history of diabetes, liver disease, human immunodeficiency virus, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, peripheral vasculature disease, dementia, connective tissues disease, leukemia, lymphoma, peptic ulcer disease, hypertension, steroid use, and use of other immunosuppressive medications. | Within 30 days of surgery (estimated to be 30 days) | |
| Secondary | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Patients will complete the Vulvar Hygiene Survey 2-3 weeks post surgery.
The after surgery section asks 6 questions about if the patient performed specific vulvar hygienic procedures |
Within 30 days of surgery (estimated to be 30 days) | |
| Secondary | Incidence of Adverse Events to Antibiotic Use | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. | Within 30 days of surgery (estimated to be 30 days) |