Trial Outcomes & Findings for Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions (NCT NCT03578965)

Last Updated: 2022-11-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Within 30 days of surgery (estimated to be 30 days)

Results posted on

2022-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: No Antibiotic Prophylaxis Prior to Skin Incision -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.	Arm B: Antibiotic Prophylaxis Prior to Skin Incision -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
Overall Study STARTED	24	26
Overall Study COMPLETED	24	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: No Antibiotic Prophylaxis Prior to Skin Incision n=24 Participants -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.	Arm B: Antibiotic Prophylaxis Prior to Skin Incision n=26 Participants -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.	Total n=50 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 10.3 • n=99 Participants	56.1 years STANDARD_DEVIATION 14.4 • n=107 Participants	53.7 years STANDARD_DEVIATION 12.7 • n=206 Participants
Sex: Female, Male Female	24 Participants n=99 Participants	26 Participants n=107 Participants	50 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=99 Participants	26 Participants n=107 Participants	50 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	9 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants	17 Participants n=107 Participants	38 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	24 participants n=99 Participants	26 participants n=107 Participants	50 participants n=206 Participants
Diagnosis of diabetes mellitus	1 Participants n=99 Participants	8 Participants n=107 Participants	9 Participants n=206 Participants
Diagnosis of HIV	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Immunosuppressive medications	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Steroid use	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Diagnosis of hypertension	6 Participants n=99 Participants	18 Participants n=107 Participants	24 Participants n=206 Participants
Diagnosis of congestive heart failure	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Diagnosis of cardiac valvular disease	0 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants
Diagnosis of coronary artery disease	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Diagnosis of chronic kidney disease	3 Participants n=99 Participants	6 Participants n=107 Participants	9 Participants n=206 Participants
Diagnosis of pulmonary disease	5 Participants n=99 Participants	12 Participants n=107 Participants	17 Participants n=206 Participants

PRIMARY outcome

Timeframe: Within 30 days of surgery (estimated to be 30 days)

Outcome measures

Outcome measures
Measure	Arm A: No Antibiotic Prophylaxis Prior to Skin Incision n=24 Participants -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.	Arm B: Antibiotic Prophylaxis Prior to Skin Incision n=26 Participants -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
Vulvar Wound Complications Compared Between the Two Arms	6 Participants	10 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A: No Antibiotic Prophylaxis Prior to Skin Incision n=24 Participants -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.	Arm B: Antibiotic Prophylaxis Prior to Skin Incision n=26 Participants -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
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	0 Participants
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	1 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	2 Participants
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	6 Participants
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	5 Participants
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	13 Participants
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	0 Participants
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	1 Participants
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	3 Participants
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	3 Participants
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	1 Participants
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	3 Participants
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	2 Participants
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	4 Participants
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	4 Participants
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	8 Participants

SECONDARY outcome

Timeframe: 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.

* 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

Outcome measures

Outcome measures
Measure	Arm A: No Antibiotic Prophylaxis Prior to Skin Incision n=24 Participants -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.	Arm B: Antibiotic Prophylaxis Prior to Skin Incision n=26 Participants -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
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	8 Participants
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	8 Participants
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	8 Participants
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	1 Participants
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	2 Participants
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	6 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Regularly performed vulvar wound care = yes postop · Vulvar wound complication(s)	5 Participants	10 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Regularly performed vulvar wound care = yes postop · No vulvar wound complication(s)	17 Participants	13 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Regularly performed vulvar wound care = no · Vulvar wound complication(s)	0 Participants	0 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Regularly performed vulvar wound care = no · No vulvar wound complication(s)	1 Participants	1 Participants
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	1 Participants
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	0 Participants
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	1 Participants
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	0 Participants
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	2 Participants
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	1 Participants
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	4 Participants
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	7 Participants
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	0 Participants
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	0 Participants
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	2 Participants
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	6 Participants
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	0 Participants
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	0 Participants
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	2 Participants
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	2 Participants
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	2 Participants
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	5 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Actively kept the vulva dry postop 14+ days · Vulvar wound complication(s)	1 Participants	4 Participants
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	7 Participants
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	0 Participants
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	0 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Actively kept the vulva dry postop = no · Vulvar wound complication(s)	1 Participants	0 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Actively kept the vulva dry postop = no · No vulvar wound complication(s)	2 Participants	2 Participants
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	0 Participants
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	0 Participants
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	4 Participants
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	0 Participants
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	1 Participants
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	5 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Cleaned the vulva after urinating postop 14+ days · Vulvar wound complication(s)	3 Participants	4 Participants
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	0 Participants
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	1 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Cleaned the vulva after urinating postop = no · Vulvar wound complication(s)	0 Participants	0 Participants
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications Cleaned the vulva after urinating postop = no · No vulvar wound complication(s)	1 Participants	2 Participants
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	0 Participants
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	0 Participants
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	3 Participants
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	1 Participants
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	1 Participants
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	4 Participants
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	4 Participants
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	6 Participants
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	1 Participants
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	0 Participants
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	2 Participants

SECONDARY outcome

Timeframe: 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

-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.

Outcome measures

Outcome measures
Measure	Arm A: No Antibiotic Prophylaxis Prior to Skin Incision -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.	Arm B: Antibiotic Prophylaxis Prior to Skin Incision n=26 Participants -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
Incidence of Adverse Events to Antibiotic Use	—	0 adverse events

Adverse Events

Arm A: No Antibiotic Prophylaxis Prior to Skin Incision

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Arm B: Antibiotic Prophylaxis Prior to Skin Incision

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Mary M. Mullen, M.D.

Washington University School of Medicine

Phone: 314-655-8750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A: No Antibiotic Prophylaxis Prior to Skin Incision n=24 participants at risk -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.	Arm B: Antibiotic Prophylaxis Prior to Skin Incision n=26 participants at risk -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
Gastrointestinal disorders Abdominal pain	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Gastrointestinal disorders Anal pain	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Gastrointestinal disorders Bloating	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Gastrointestinal disorders Gastroenteritis	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Gastrointestinal disorders Hemorrhoid	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
General disorders Fatigue	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
General disorders Minimal pain	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
General disorders Pain	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
General disorders Swollen sensation	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Infections and infestations Urinary tract infection	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Infections and infestations Vulvar infection	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Bloody discharge	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Discolored suture	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Easy bruising	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Vulvar bleeding	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Vulvar discomfort	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Vulvar wound dehiscence	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Vulvar wound drainage	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	7.7% 2/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Vulvar/vaginal discharge	16.7% 4/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Vulvar/vaginal spotting	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Injury, poisoning and procedural complications Wound separation	20.8% 5/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	15.4% 4/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Nervous system disorders Dizziness	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Nervous system disorders Headache	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Psychiatric disorders Anxiety	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Psychiatric disorders Depression	8.3% 2/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Psychiatric disorders Mood changes	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Renal and urinary disorders Bladder prolapse	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Renal and urinary disorders Hematuria	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Renal and urinary disorders Incontinence	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Reproductive system and breast disorders Pain with intercourse	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Reproductive system and breast disorders Vaginal bleeding	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Reproductive system and breast disorders Vulvar pain	37.5% 9/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	34.6% 9/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Respiratory, thoracic and mediastinal disorders Cough	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Skin and subcutaneous tissue disorders Alopecia	4.2% 1/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	0.00% 0/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Skin and subcutaneous tissue disorders Arm and thigh itching	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Skin and subcutaneous tissue disorders Lichen sclerosus	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Skin and subcutaneous tissue disorders Vulvar pruritus	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
Skin and subcutaneous tissue disorders Vulvar rash	0.00% 0/24 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)	3.8% 1/26 • Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)