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Active, Not Recruiting

NCT Number: NCT04407364

MPM Medical CoMatryx Surgical Bovine Collagen Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Surgical Wound, Healed Surgical Wound Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Center for Joint Replacement

Plano, Texas, 75093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoMatryx Surgical Bovine Collagen

Device

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

Primary outcomes

  1. CoMatryx Surgical Bovine Collagen

    Time frame: 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.

    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)

  2. CoMatryx Surgical Bovine Collagen Height and Weight

    Time frame: 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.

    Height and Weight will be combined as BMI(kg/m^2)

Secondary outcomes

  1. Bovine Collagen

    Time frame: 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.

    The secondary objective is the assessment of clinical benefits by analyzing recorded subject-reported pain scores

Sponsors and collaborators

Lead sponsor

MPM Medical

Industry

Collaborators

  • Texas Health Resources

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
May 29, 2020
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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