Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04407364 |
Other study ID # |
MPMCOM20 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 2, 2020 |
Est. completion date |
January 2, 2025 |
Study information
Verified date |
November 2023 |
Source |
MPM Medical |
Contact |
Scott Miller |
Phone |
9728934049 |
Email |
scott.miller[@]mpmmed.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.