MPM Medical CoMatryx Surgical Bovine Collagen Study

NCT ID: NCT04407364

Last Updated: 2024-07-05

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-02

Study Completion Date

2025-05-02

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.

Conditions

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Surgical Wound, Healed

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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Interventional Cohort Historical Cohort with no intervention

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Health Resources

OTHER

Sponsor Role collaborator

MPM Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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MPMCOM20

Identifier Type: -

Identifier Source: org_study_id

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