MPM Medical CoMatryx Surgical Bovine Collagen Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The CoMatryx Surgical Collagen Powder is a Soft Tissue Repair Product Made of 100% Type I Bovine Collagen

Conditions
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Surgical Wound, Healed

Intervention / Treatment
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* Device: CoMatryx Surgical Bovine Collagen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention Cohort<br>The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen | Device: CoMatryx Surgical Bovine Collagen<br>* The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen<br>* Other names: Historical Cohort with no intervention;|
| Historical Cohort<br>Primary and Revision total hip arthroplasty patients between 18-85 years of age | Device: CoMatryx Surgical Bovine Collagen<br>* The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen<br>* Other names: Historical Cohort with no intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |