Surgical Wound, HealedNCT04407364
MPM Medical CoMatryx Surgical Bovine Collagen Study
An observational study of Surgical Wound, Healed, run by MPM Medical at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound, Healed
- What is being tested?
- CoMatryx Surgical Bovine Collagen
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2020to 2 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary and Revision total hip arthroplasty patients between 18-85 years of age
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Center for Joint Replacement
Plano, Texas, 75093
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Wound, Healed
- Being tested
- CoMatryx Surgical Bovine Collagen
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoMatryx Surgical Bovine CollagenDevice
Also called Interventional Cohort, Historical Cohort with no intervention
The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen
| Study group | Role | What they receive |
|---|---|---|
| Intervention Cohort | The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen Receives: Device: CoMatryx Surgical Bovine Collagen | |
| Historical Cohort | Primary and Revision total hip arthroplasty patients between 18-85 years of age Receives: Device: CoMatryx Surgical Bovine Collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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 outcomes (1)
Bovine Collagen
The secondary objective is the assessment of clinical benefits by analyzing recorded subject-reported pain scores
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start2 Sep 2020
- Primary completion2 Apr 2024
- Study completion2 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound, HealedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- MPM Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas Health Resources
- Responsible party
- Sponsor
- Investigators
- Kwame Ennin, MD, Principal investigator, Texas Health Physicians Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407364
- Sponsor's protocol ID
- MPMCOM20
- Status last verified
- Jul 2024
- First submitted
- 20 May 2020
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CoMatryx Surgical Collagen Powder is a Soft Tissue Repair Product Made of 100% Type I Bovine Collagen
- ClinicalTrials.gov ID
- NCT04407364
- Acronym / sponsor ID
- MPMCOM20
- Conditions
- Surgical Wound, Healed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- MPM MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Texas Health Resources
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 May 2025 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Cohort | – | Device: CoMatryx Surgical Bovine CollagenThe CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen |
| Historical Cohort | – | Device: CoMatryx Surgical Bovine CollagenPrimary and Revision total hip arthroplasty patients between 18-85 years of age |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary and Revision total hip arthroplasty patients between 18-85 years of age
Key inclusion criteria (6 listed)
- • Subjects must be 18 years of age or older
Key exclusion criteria (5 listed)
- • Subjects more than 85 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoMatryx Surgical Bovine CollagenAlso: Interventional Cohort, Historical Cohort with no interventionThe CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen | Device | Historical Cohort, Intervention Cohort |
Primary outcome
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)
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)
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Surgical Wound, Healed
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care
Wound Healing, Abdominal Surgery
Not yet recruitingPhase 1
Amnion Membrane Powder Mohs Study
Wound Heal
RecruitingObservational study
Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery
Diabetic Foot Ulcer, Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwame Ennin, MD principal investigator
Texas Health Physicians Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound, Healed, run by MPM Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.