Benign Vulvar Lesion, Premalignant Vulvar Lesion
Conditions
Brief summary
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.
Interventions
DRUGCefazolin
-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vulvar Wound Complications Compared Between the Two Arms | Within 30 days of surgery (estimated to be 30 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | 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. |
| Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Within 30 days of surgery (estimated to be 30 days) | * 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 |
| Incidence of Adverse Events to Antibiotic Use | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision. | 24 |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines. | 26 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Arm A: No Antibiotic Prophylaxis Prior to Skin Incision |
|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 12.7 | 56.1 years STANDARD_DEVIATION 14.4 | 51.1 years STANDARD_DEVIATION 10.3 |
| Diagnosis of cardiac valvular disease | 6 Participants | 6 Participants | 0 Participants |
| Diagnosis of chronic kidney disease | 9 Participants | 6 Participants | 3 Participants |
| Diagnosis of congestive heart failure | 1 Participants | 1 Participants | 0 Participants |
| Diagnosis of coronary artery disease | 5 Participants | 4 Participants | 1 Participants |
| Diagnosis of diabetes mellitus | 9 Participants | 8 Participants | 1 Participants |
| Diagnosis of HIV | 1 Participants | 1 Participants | 0 Participants |
| Diagnosis of hypertension | 24 Participants | 18 Participants | 6 Participants |
| Diagnosis of pulmonary disease | 17 Participants | 12 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 26 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Immunosuppressive medications | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 17 Participants | 21 Participants |
| Region of Enrollment United States | 50 participants | 26 participants | 24 participants |
| Sex: Female, Male Female | 50 Participants | 26 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Steroid use | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 26 |
| other Total, other adverse events | 20 / 24 | 17 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
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.
Time frame: Within 30 days of surgery (estimated to be 30 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Vulvar Wound Complications Compared Between the Two Arms | 6 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Vulvar Wound Complications Compared Between the Two Arms | 10 Participants |
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
Time frame: Within 30 days of surgery (estimated to be 30 days)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 14+ days | Vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Chose to not sit and to lie/stand when possible = yes | No vulvar wound complication(s) | 16 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Chose to not sit and to lie/stand when possible = no | Vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Chose to not sit and to lie/stand when possible = no | No vulvar wound complication(s) | 2 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Regularly performed vulvar wound care = yes postop | Vulvar wound complication(s) | 5 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Regularly performed vulvar wound care = yes postop | No vulvar wound complication(s) | 17 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Regularly performed vulvar wound care = no | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Regularly performed vulvar wound care = no | No vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times a day postop for 1-2 days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times a day postop for 1-2 days | No vulvar wound complication(s) | 3 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 3-7 days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 3-7 days | No vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 8-14 days | Vulvar wound complication(s) | 5 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 8-14 days | No vulvar wound complication(s) | 4 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Chose to not sit and to lie/stand when possible = yes | Vulvar wound complication(s) | 5 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 14+ days | No vulvar wound complication(s) | 5 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for unknown # of days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for unknown # of days | No vulvar wound complication(s) | 2 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop = no | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop = no | No vulvar wound complication(s) | 4 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 1-2 days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 1-2 days | No vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 3-7 days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 3-7 days | No vulvar wound complication(s) | 2 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 8-14 days | Vulvar wound complication(s) | 4 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 8-14 days | No vulvar wound complication(s) | 7 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 14+ days | Vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 14+ days | No vulvar wound complication(s) | 5 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop for unknown # of days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop for unknown # of days | No vulvar wound complication(s) | 2 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop = no | Vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop = no | No vulvar wound complication(s) | 2 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 1-2 days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 1-2 days | No vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 3-7 days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 3-7 days | No vulvar wound complication(s) | 2 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 8-14 days | Vulvar wound complication(s) | 3 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 8-14 days | No vulvar wound complication(s) | 7 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 14+ days | Vulvar wound complication(s) | 3 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 14+ days | No vulvar wound complication(s) | 7 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop for unknown # of days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop for unknown # of days | No vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop = no | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop = no | No vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 1-2 days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 1-2 days | No vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 3-7 days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 3-7 days | No vulvar wound complication(s) | 3 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 8-14 days | Vulvar wound complication(s) | 3 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 8-14 days | No vulvar wound complication(s) | 7 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 14+ days | Vulvar wound complication(s) | 3 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 14+ days | No vulvar wound complication(s) | 6 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop for unknown # of days | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop for unknown # of days | No vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop = no | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop = no | No vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop for unknown # of days | Vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Chose to not sit and to lie/stand when possible = yes | Vulvar wound complication(s) | 8 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop for unknown # of days | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Chose to not sit and to lie/stand when possible = yes | No vulvar wound complication(s) | 8 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop = no | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Chose to not sit and to lie/stand when possible = no | Vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop for unknown # of days | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Chose to not sit and to lie/stand when possible = no | No vulvar wound complication(s) | 6 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 8-14 days | No vulvar wound complication(s) | 4 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Regularly performed vulvar wound care = yes postop | Vulvar wound complication(s) | 10 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop = no | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Regularly performed vulvar wound care = yes postop | No vulvar wound complication(s) | 13 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop = no | No vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Regularly performed vulvar wound care = no | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop = no | No vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Regularly performed vulvar wound care = no | No vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop = no | Vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times a day postop for 1-2 days | Vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 1-2 days | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times a day postop for 1-2 days | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 1-2 days | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 3-7 days | Vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 1-2 days | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 3-7 days | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 14+ days | Vulvar wound complication(s) | 4 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 8-14 days | Vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 3-7 days | Vulvar wound complication(s) | 4 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 8-14 days | No vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 1-2 days | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 14+ days | Vulvar wound complication(s) | 4 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 3-7 days | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 14+ days | No vulvar wound complication(s) | 7 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop for unknown # of days | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for unknown # of days | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 8-14 days | Vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for unknown # of days | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 3-7 days | Vulvar wound complication(s) | 3 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop = no | Vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 8-14 days | No vulvar wound complication(s) | 5 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Performed sitz baths or cleansed with a showerhead 2-3 times per day postop = no | No vulvar wound complication(s) | 6 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 14+ days | No vulvar wound complication(s) | 6 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 1-2 days | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 14+ days | Vulvar wound complication(s) | 4 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 1-2 days | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 3-7 days | No vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 3-7 days | Vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop 14+ days | No vulvar wound complication(s) | 8 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 3-7 days | No vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop = no | No vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 8-14 days | Vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop for unknown # of days | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 8-14 days | No vulvar wound complication(s) | 5 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after having a bowel movement postop 8-14 days | Vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 14+ days | Vulvar wound complication(s) | 4 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Cleaned the vulva after urinating postop for unknown # of days | No vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications | Actively kept the vulva dry postop 14+ days | No vulvar wound complication(s) | 7 Participants |
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.
Time frame: Within 30 days of surgery (estimated to be 30 days)
Population: The number analyzed for each row equals the number of participants who had the listed pre-existing condition or medication.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | HIV | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | HIV | No vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Immunosuppressive medications | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Immunosuppressive medications | No vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Steroid use | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Steroid use | No vulvar wound complication(s) | 2 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Diabetes mellitus | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Diabetes mellitus | No vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Hypertension | Vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Hypertension | No vulvar wound complication(s) | 5 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Congestive heart failure | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Congestive heart failure | No vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Cardiac valvular disease | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Cardiac valvular disease | No vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Coronary artery disease | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Coronary artery disease | No vulvar wound complication(s) | 1 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Chronic kidney disease | Vulvar wound complication(s) | 0 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Chronic kidney disease | No vulvar wound complication(s) | 3 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Pulmonary disease | Vulvar wound complication(s) | 2 Participants |
| Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Pulmonary disease | No vulvar wound complication(s) | 3 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Chronic kidney disease | No vulvar wound complication(s) | 4 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | HIV | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Congestive heart failure | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | HIV | No vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Coronary artery disease | No vulvar wound complication(s) | 3 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Immunosuppressive medications | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Congestive heart failure | No vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Immunosuppressive medications | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Pulmonary disease | No vulvar wound complication(s) | 8 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Steroid use | Vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Cardiac valvular disease | Vulvar wound complication(s) | 3 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Steroid use | No vulvar wound complication(s) | 0 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Chronic kidney disease | Vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Diabetes mellitus | Vulvar wound complication(s) | 2 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Cardiac valvular disease | No vulvar wound complication(s) | 3 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Diabetes mellitus | No vulvar wound complication(s) | 6 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Pulmonary disease | Vulvar wound complication(s) | 4 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Hypertension | Vulvar wound complication(s) | 5 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Coronary artery disease | Vulvar wound complication(s) | 1 Participants |
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Hypertension | No vulvar wound complication(s) | 13 Participants |
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.
Time frame: Within 30 days of surgery (estimated to be 30 days)
Population: Only participants in Arm B who received antibiotic prophylaxis are evaluable for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm B: Antibiotic Prophylaxis Prior to Skin Incision | Incidence of Adverse Events to Antibiotic Use | 0 adverse events |