Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
72 participants
OBSERVATIONAL
2020-09-02
2025-05-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Intervention Cohort
The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen
CoMatryx Surgical Bovine Collagen
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
CoMatryx Surgical Bovine Collagen
The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen
Interventions
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CoMatryx Surgical Bovine Collagen
The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
Yes
Sponsors
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Texas Health Resources
OTHER
MPM Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Kwame Ennin, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Health Physicians Group
Locations
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Texas Center for Joint Replacement
Plano, Texas, United States
Countries
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Other Identifiers
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MPMCOM20
Identifier Type: -
Identifier Source: org_study_id
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