Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Vulvar Wound Complications Compared Between the Two Arms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Arm B: Antibiotic prophylaxis prior to skin incision
-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
干预措施: Cefazolin (Drug)
结局指标
主要结局
Vulvar Wound Complications Compared Between the Two Arms
时间窗: 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.
次要结局
- 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))
- Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications(Within 30 days of surgery (estimated to be 30 days))
- Incidence of Adverse Events to Antibiotic Use(Within 30 days of surgery (estimated to be 30 days))