The CoMatryx Surgical Collagen Powder is a Soft Tissue Repair Product Made of 100% Type I Bovine Collagen
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- CoMatryx Surgical Bovine Collagen
研究概览
简要总结
The objective of this prospective enrollment study is to collect data confirming safety, performance and clinical benefits of the CoMatryx Surgical Collagen powder at a minimum 1-year follow-up and compare it to a historical control group who did not receive the product at the time of surgery.
The primary objective is to confirm safety and clinical benefits of the product. This will be assessed by recording the rate of wound healing and incidence and frequency of wound care related complications. Relationship of complications to the product should be specified.
详细描述
The CoMatryx Surgical Collagen powder is a soft tissue repair product made of 100% Type I Bovine collagen. It is non-hydrolyzed and not cross-linked chemically. It is biocompatible, biodegradable and free of synthetics. The product does not have any specific storage requirements.
The CoMatryx Surgical Collagen powder provides a physiologically favorable environment to promote healing at the wound site. When administered, the powder conforms to the wound site and forms a gelatinous occlusive barrier. Along with providing 19 amino acids directly to the wound site it also occludes live nerve endings reducing pain. Treating the wound with the CoMatryx Surgical Collagen powder provides the non-hydrolyzed collagen wound surface promoting autolytic debridement. The powder is effective in all phases of wound healing and can be delivered with antibiotics in areas where there may be a cavity. This product has FDA 510(k) clearance for surgical wounds, full thickness wounds, traumatic wounds and skin tears.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Subjects must be 18 years of age or older
- •Subject must be willing and able to sign IRB approved informed consent
- •Subject must have a BMI of 35 or higher
- •Surgical approach of only ASI (anterior supine)
- •Primary total hip arthroplasty
- •Revision total hip arthroplasty
排除标准
- •• Subjects more than 85 years of age
- •Subjects who will be or have undergone bilateral total hip replacements
- •Subject is known to be pregnant or nursing
- •Subject is an alcohol or drug abuser
- •Subject has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
结局指标
主要结局
CoMatryx Surgical Bovine Collagen
时间窗: This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.
The primary objective is to confirm safety and performance of the study product. This will be assessed by recording the rate of healing, incidence and frequency of complications and adverse events relative to the surgical incision at 1-week, 2-week, 6-week, 6-month and 1-year follow-up. Height and Weight will be combined as BMI(kg/m\^2)
CoMatryx Surgical Bovine Collagen Height and Weight
时间窗: This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.
Height and Weight will be combined as BMI(kg/m\^2)
次要结局
- Bovine Collagen(This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.)