Wounds and Injuries

All Conditions

Neoplasms

Precancerous Conditions

Anti-Infective Agents

All Drugs and Chemicals

Cefazolin

Anti-Bacterial Agents

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Penicillins

Antibiotics, Antitubercular

-Women randomized to no antibiotic prophylaxis will not receive any antibiotics 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

Mary M Mullen, M.D.

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.

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

Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions

Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial

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 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.

* 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

-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.

Washington University School of Medicine

Arm A: No Antibiotic Prophylaxis Prior to Skin Incision

Arm B: Antibiotic Prophylaxis Prior to Skin Incision

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Diagnosis of diabetes mellitus

Diagnosis of HIV

Immunosuppressive medications

Steroid use

Diagnosis of hypertension

Diagnosis of congestive heart failure

Diagnosis of cardiac valvular disease

Diagnosis of coronary artery disease

Diagnosis of chronic kidney disease

Diagnosis of pulmonary disease

Mary M. Mullen, M.D.

Vulvar Wound Complications Compared Between the Two Arms

Diabetes mellitus

Hypertension

Congestive heart failure

Cardiac valvular disease

Coronary artery disease

Chronic kidney disease

Pulmonary disease

The number analyzed for each row equals the number of participants who had the listed pre-existing condition or medication.

Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection

Chose to not sit and to lie/stand when possible = yes

Chose to not sit and to lie/stand when possible = no

Regularly performed vulvar wound care = yes postop

Regularly performed vulvar wound care = no

Performed sitz baths or cleansed with a showerhead 2-3 times a day postop for 1-2 days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 3-7 days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 8-14 days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 14+ days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for unknown # of days

Performed sitz baths or cleansed with a showerhead 2-3 times per day postop = no

Actively kept the vulva dry postop 1-2 days

Actively kept the vulva dry postop 3-7 days

Actively kept the vulva dry postop 8-14 days

Actively kept the vulva dry postop 14+ days

Actively kept the vulva dry postop for unknown # of days

Actively kept the vulva dry postop = no

Cleaned the vulva after urinating postop 1-2 days

Cleaned the vulva after urinating postop 3-7 days

Cleaned the vulva after urinating postop 8-14 days

Cleaned the vulva after urinating postop 14+ days

Cleaned the vulva after urinating postop for unknown # of days

Cleaned the vulva after urinating postop = no

Cleaned the vulva after having a bowel movement postop 1-2 days

Cleaned the vulva after having a bowel movement postop 3-7 days

Cleaned the vulva after having a bowel movement postop 8-14 days

Cleaned the vulva after having a bowel movement postop 14+ days

Cleaned the vulva after having a bowel movement postop for unknown # of days

Cleaned the vulva after having a bowel movement postop = no

The number analyzed in the rows below do not match the overall number of participants analyzed in some categories because the participant did not answer the question on the survey.

Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications

Only participants in Arm B who received antibiotic prophylaxis are evaluable for this outcome measure

Incidence of Adverse Events to Antibiotic Use

Overall Study

Spots Global Cancer Trial Database for Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions

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