A Prospective Multicenter Single-arm Clinical Study to Investigate Clinical Outcomes When Cohealyx™ is Used for the Management of Full Thickness Wounds Post-surgical Excision
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 18
- 主要终点
- Time for Cohealyx to generate tissue capable of supporting definitive closure
研究概览
简要总结
The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds. The main question it aims to answer is how long does it take for Cohealyx to support definitive closure.
详细描述
This is a prospective single-arm post-market multicenter study to evaluate clinical outcomes of Cohealyx when used to manage full thickness wounds post-surgical excision. A systematic literature review and meta-analysis were conducted to establish a performance goal for the primary effectiveness endpoint (time to autografting).
Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury.
Following placement of Cohealyx, investigators will evaluate the wound every 3 days. Once Cohealyx has successfully integrated into the wound bed, as indicated by a robust vascularized tissue bed, the wound bed will be prepared and autografted per the investigative site's standard of care.
The study area will be evaluated with respect to Cohealyx integration, time to autografting, autograft take, healing, and safety-related adverse events.
Post-autografting, subjects will be followed for 6.5 months. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas as well as any donor sites dressed in PermeaDerm will be documented using digital photography.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all the following criteria to be eligible for participation:
- •The patient has a staged surgical procedure planned that requires autografting for treatment of a full thickness wound.
- •The patient is hospitalized within 3 days of injury.
- •The surgical excision occurs within 5 days post-injury.
- •The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
- •The patient (or parent/guardian/legally authorized representative) agrees to abstain from any other treatment of the study area or enrollment in another interventional clinical trial for the duration of his/her participation in the study (26 weeks post-autografting).
- •In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
- •Understand the full nature and purpose of the study, including possible risks and adverse events,
- •Understand instructions, and
- •Provide voluntary written informed consent
排除标准
- •Subjects who meet any of the following criteria are not eligible for participation:
- •Clinical signs of wound infection at study area.
- •The patient has a medical condition, is using medications or receiving treatments (e.g., immune deficiency) that may compromise patient safety or the trial evaluations or objectives.
- •The patient is unable to understand English or Spanish.
- •The patient has a known hypersensitivity to bovine-derived collagen, porcine, or aloe vera materials.
- •Presence of a medical condition where the patient's life expectancy is less than 1 year (e.g., malignancy).
研究组 & 干预措施
Cohealyx
Cohealyx application post surgical excision
干预措施: Cohealyx (Device)
结局指标
主要结局
Time for Cohealyx to generate tissue capable of supporting definitive closure
时间窗: Up to 30 days
Defined as the number of days from placement of Cohealyx until placement of an autologous split-thickness skin graft
次要结局
未报告次要终点