Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/14/2019 |
| Start Date: | July 13, 2018 |
| End Date: | August 31, 2019 |
| Contact: | Mary M Mullen, M.D. |
| Email: | marymullen@wustl.edu |
| Phone: | (314) 655-8750 |
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
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.
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.
Inclusion Criteria:
- All women, >=18 and <=85 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 or breastfeeding
- Women scheduled to undergo a radical vulvectomy
- Women scheduled to undergo a concomitant graft, flap or plastic surgery
- Women <18 years of age or >=85 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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Mary M Mullen, M.D.
Phone: 314-655-8750
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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