NCT06910189尚未招募不适用
Use of Fish Skin Graft (FSG) to Improve Wound Healing and Expedite Discharge at a County Safety-net Hospital
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年4月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Hospital length of stay
研究概览
简要总结
The purpose of this study is to estimate the effect of FSG (Kerecis) on hospital length of stay among adult patients with surgical wounds of at least 40cm2 requiring surgical debridement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients and nursing staff will be blinded to the patient's study arm. The operative physician will not be blinded
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
- •Has wound greater than or equal to 40cm2 requiring surgical debridement
- •Agreeable to follow up period of up to 1 year
排除标准
- •Patients with wounds that do not require surgical debridement.
- •Patients with a known allergy or other sensitivity to fish material
- •Patients who are deemed unlikely to follow up (e.g., patients who live out of state).
- •Patients in police custody/incarcerated.
- •Patients unable to communicate in either Spanish or English.
结局指标
主要结局
Hospital length of stay
时间窗: from time of admission to time of discharge (about 3 days from date of surgery)
次要结局
- Number of participants that have recurrent surgical site infection(Upto 1 year after surgery)
- Number of participants that require reoperation(Upto 1 year after surgery)
- Time to total wound healing(From end of surgery to upto 1 year after surgery)
- Number of participants that need skin graft(Upto 1 year after surgery)
- time from original surgery with placement of wound vac until the patient gets a skin graft(upto 1 year after surgery)
- time to return to work(From discharge (about 3 days from date of surgery) upto 1 year after surgery)
- Number of participants that need wound vac after discharge(At discharge (about 3 days from date of surgery))
- Inpatient hospital costs(At discharge (about 3 days from date of surgery))
- financial toxicity experienced by patients as assessed by the COST - FACIT survey(6 months after discharge)
- financial toxicity experienced by patients as assessed by the COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (FACIT) survey(12 months after discharge)
研究者
Jonah Stulberg
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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