NCT06070454招募中不适用
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- the rate of perioperative vulvovaginitis
研究概览
简要总结
Primary:
- To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
- To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.
详细描述
Primary:
- To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
- To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Must be 18 years of age
- •Has histologically confirmed non-malignant vulvar pathology
- •Is scheduled or planning for WLE/SPV
- •Signed informed consent obtained prior to any protocol specific procedures
排除标准
- •Unable to give informed consent
- •Women who are pregnant or nursing (lactating) women at time of consent
- •No prior RT
- •No recent antibiotic use within the last 3 weeks or 5.5 times the half-life of the antibiotic (whichever is shorter)
- •No history of prior malignancy within the last 3 years that required systemic chemotherapy or radiation
- •Not immunosuppressed or compromised
- •No active HIV (must have undetectable viral load)
- •Chronic treatment with corticosteroids or other immunosuppressive agents including topical corticosteroids in the pelvis. Inhaled corticosteroids are allowed
- •No active uncontrolled severe infections (not responding to antibiotics), except acute or chronic pelvic inflammatory disease
- •Uncontrolled diabetes mellitus
结局指标
主要结局
the rate of perioperative vulvovaginitis
时间窗: 8 weeks
To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown
时间窗: 8 weeks
To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease
次要结局
未报告次要终点
研究者
Carrie Sopata
Associate Professor
University of Virginia
研究点 (2)
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