MPM Medical CoMatryx Surgical Bovine Collagen Study
关键词
抽象
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.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 05/19/2020 |
| 提交的预估入学人数: | 05/26/2020 |
| 首次发布: | 05/28/2020 |
| 上次提交的更新: | 05/28/2020 |
| 最近更新发布: | 06/01/2020 |
| 实际学习开始日期: | 05/31/2020 |
| 预计主要完成日期: | 05/31/2022 |
| 预计完成日期: | 05/31/2022 |
状况或疾病
干预/治疗
Device: CoMatryx Surgical Bovine Collagen
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Intervention Cohort The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen | |
| Historical Cohort Primary and Revision total hip arthroplasty patients between 18-85 years of age |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - • 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 Exclusion Criteria: - • 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 |
结果
主要结果指标
1. CoMatryx Surgical 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.]
2. CoMatryx Surgical Bovine Collagen Height and Weight [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.]
次要成果指标
1. 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.]
