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| Name | Class |
|---|---|
| Texas Health Resources | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoMatryx Surgical Bovine Collagen | Device | The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen |
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| Measure | Description | Time Frame |
|---|---|---|
| CoMatryx Surgical Bovine Collagen | 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) | 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. |
| CoMatryx Surgical Bovine Collagen Height and Weight | Height and Weight will be combined as BMI(kg/m^2) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bovine Collagen | The secondary objective is the assessment of clinical benefits by analyzing recorded subject-reported pain scores | 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. |
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Inclusion Criteria:
• Subjects must be 18 years of age or older
Exclusion Criteria:
• Subjects more than 85 years of age
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Primary and Revision total hip arthroplasty patients between 18-85 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Kwame Ennin, MD | Texas Health Physicians Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Center for Joint Replacement | Plano | Texas | 75093 | United States |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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