MPM Medical CoMatryx Surgical Bovine Collagen Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound, Healed
• Intervention / Treatment: Device: CoMatryx Surgical Bovine Collagen

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Scott Miller; Phone Number: 9728934049; Email: scott.miller@mpmmed.com
• Study Contact Backup: Name: Shuvie Dasgupta; Phone Number: 9729817114; Email: ShuvalaxmiDasgupta@texashealth.org

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • Recruiting
      • Texas Center for Joint Replacement
      • Contact: Shuvie Dasgupta; Phone Number: 972-981-7114; Email: shuvalaxmidasgupta@texashealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Primary and Revision total hip arthroplasty patients between 18-85 years of age

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: MPM Medical
• Collaborators: Texas Health Resources
• Investigators: Principal Investigator: Kwame Ennin, MD, Texas Health Physicians Group

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Estimated): December 2, 2024
• Study Completion (Estimated): January 2, 2025

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: MPMCOM20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No