Closure Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fistula healing
研究概览
简要总结
The purpose of this study is to determine feasibility of Kerecis intact fish skin for healing of fistula-in-ano and associated non-healing draining wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age ≥18 years old
- •Cryptoglandular fistula-in-ano (primary or recurrent)
- •The ability to give appropriate consent
排除标准
- •Age <18 years old
- •Pregnant (as determined by urine test)
- •Any known allergies or sensitivities to fish material
- •Prisoners
- •Inflammatory bowel disease
- •Fistula-in-ano associated with:
- •Anal cancer
- •Rectal cancer
- •Extramammary Paget's disease
- •Hidradenitis suppurativa
- •Anal condyloma
- •Active infection / abscess
研究组 & 干预措施
Intact Kerecis Fish Skin
To assess shot-term outcomes (rates of healing) using Kerecis intact fish skin to heal cryptoglandular fistula-in-ano and associated chronic non-healing draining wounds.
干预措施: Kerecis fish skin (Device)
结局指标
主要结局
Fistula healing
时间窗: From device implant until 6 months after
Assess healing of the fistula. This will be determined based on physical examination. A healed fistula will be a patient who 6 months after surgery no longer has drainage or evidence of infection. The internal opening should be closed on physical exam. The internal opening should feel closed on digital rectal exam. This will be assessed in each patient to determine the overall rate of healing.
Fistula healing
时间窗: From device implant until 6 months after
Assess healing of the fistula. This will be determined based on physical examination. A healed fistula will be a patient who 6 months after surgery no longer has drainage or evidence of infection. The internal opening should be closed on physical exam. The internal opening should feel closed on digital rectal exam. This will be assessed in each patient to determine the overall rate of healing.
次要结局
未报告次要终点
研究者
Nicholas P. McKenna
Principal Investigator
Mayo Clinic