Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions
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|ClinicalTrials.gov Identifier: NCT03578965|
Recruitment Status : Active, not recruiting
First Posted : July 6, 2018
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Premalignant Vulvar Lesion Benign Vulvar Lesion||Drug: Cefazolin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The principal investigator along with all members of the study team involved in data analysis as well as the patients will be blinded to the randomization group. The research assistant will disclose the randomization group to the anesthesiologist who will screen the patient for allergies and then obtain the appropriate antibiotics from the pharmacy and administer the antibiotics as appropriate. These will be administered prior to the procedure and so the surgeon will remain blinded to the administration|
|Official Title:||Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial|
|Actual Study Start Date :||July 13, 2018|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Arm 1: Antibiotic prophylaxis prior to skin incision
-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision
No Intervention: Arm 1: No antibiotic prophylaxis prior to skin incision
-Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.
- Vulvar wound complications compared between the two arms [ Time Frame: Within 30 days of surgery (estimated to be 30 days) ]
-a) 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.
- Clinical risk factors that correlate with vulvar wound complications as measured by demographic variables that predispose patients to infection [ Time Frame: Within 30 days of surgery (estimated to be 30 days) ]-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.
- Clinical risk factors that correlate with vulvar wound complications as measured by vulvar hygiene [ Time Frame: Within 30 days of surgery (estimated to be 30 days) ]
- Patients will complete the Vulvar Hygiene Survey 2-3 weeks post surgery and the survey is split into two sections - prior to surgery and after surgery.
- The prior to surgery survey asks 6 questions with yes/no answer choices. The questions ask the patient's doctor if he/she informed them about vulvar hygiene
- The after surgery section asks 4 questions about if the patient performed specific vulvar hygienic procedures
- Incidence of adverse events to antibiotic use [ Time Frame: Within 30 days of surgery (estimated to be 30 days) ]-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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578965
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Mary M Mullen, M.D.||Washington University School of Medicine|