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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2, 2025
Est. primary completion date December 2, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
CoMatryx Surgical Bovine Collagen
The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen

Locations

Country Name City State
United States Texas Center for Joint Replacement Plano Texas

Sponsors (2)

Lead Sponsor Collaborator
MPM Medical Texas Health Resources

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 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.
See also
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Withdrawn NCT04038671 - Activated Carbon Interphase Effect on Surgical Incisions vs.Two Common Wound Dressings N/A