MPM Medical CoMatryx Surgical Bovine Collagen Study

Phase

N/A

Condition

Pressure Ulcer

Treatment

CoMatryx Surgical Bovine Collagen

Clinical Study ID

NCT04407364

MPMCOM20

Ages 18-85
All Genders
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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

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 forproper informed consent

Study Design

CoMatryx Surgical Bovine Collagen

September 02, 2020

May 02, 2025

Study 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.

Connect with a study center

Texas Center for Joint Replacement
Plano, Texas 75093
United States
Site Not Available

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