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MPM Medical CoMatryx Surgical Bovine Collagen Study

NCT04407364 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2024-07-05

No results posted yet for this study

Summary

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.

Conditions

  • Surgical Wound, Healed

Interventions

DEVICE

CoMatryx Surgical Bovine Collagen

The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen

Sponsors & Collaborators

  • Texas Health Resources

    collaborator OTHER

  • MPM Medical

    lead INDUSTRY

Principal Investigators

  • Kwame Ennin, MD · Texas Health Physicians Group

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2024-04-02
Completion
2025-05-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04407364 on ClinicalTrials.gov