40 Participants Needed

Cohealyx for Full Thickness Wounds

(Cohealyx I Trial)

Recruiting at 14 trial locations
EK
Overseen ByElizabeth Kirshner
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Avita Medical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Cohealyx, a collagen matrix, to evaluate its effectiveness in healing full-thickness wounds after surgery. Researchers aim to determine how quickly Cohealyx can completely close these wounds. Individuals scheduled for surgery requiring a skin graft and hospitalized shortly after their injury may be suitable candidates. The study involves only Cohealyx treatment after cleaning the surgical area. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from a novel treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using medications that might affect your safety or the trial's evaluations, you may not be eligible to participate.

What prior data suggests that Cohealyx is safe for treating full thickness wounds?

Research has shown that Cohealyx, a skin substitute made from collagen, is designed to help heal wounds. This treatment supports tissue joining and promotes the growth of new blood vessels, which can speed up recovery. The FDA has approved Cohealyx for other wound care uses, indicating it meets certain safety standards. Although detailed information on side effects remains unavailable, FDA approval suggests Cohealyx is generally safe. This offers a hopeful outlook for its use in treating deep wounds.12345

Why are researchers excited about this trial?

Cohealyx is unique because it introduces a novel approach to healing full-thickness wounds. Unlike traditional treatments like skin grafts or synthetic dressings that primarily cover or close the wound, Cohealyx is applied post-surgical excision to potentially enhance the body's natural healing processes. Researchers are excited about Cohealyx because it might offer a more efficient healing process, reducing recovery time and improving overall outcomes for patients with deep, severe wounds. This could be a game-changer, especially for those who struggle with slow-healing wounds.

What evidence suggests that Cohealyx might be an effective treatment for full thickness wounds?

Research has shown that Cohealyx Collagen Matrix may help heal deep wounds. Animal studies found that Cohealyx can create strong tissue, which supports skin grafts effectively. The matrix quickly absorbs blood and fluids, accelerating the healing process. This technology aims to help wounds close completely by providing a solid base for new skin growth. Although more information from human trials is needed, these early findings suggest Cohealyx could be a valuable tool for wound care.12678

Are You a Good Fit for This Trial?

This trial is for patients with full thickness wounds needing skin grafts. They must be hospitalized within 3 days of injury, have surgery within 5 days, and commit to the study's procedures for 26 weeks post-grafting without seeking other treatments or joining another trial.

Inclusion Criteria

I am willing and able to follow all study requirements.
I agree not to join other clinical trials or receive other treatments for my condition for 26 weeks.
I understand the study's purpose, risks, and possible side effects.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Cohealyx is applied to the surgically excised wound bed within 5 days post-injury

Up to 30 days
Every 3 days (in-person)

Autografting

Once Cohealyx has integrated, the wound bed is prepared and autografted

1 week

Follow-up

Participants are monitored for healing, safety, and adverse events post-autografting

6.5 months
Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cohealyx
Trial Overview The study tests Cohealyx Collagen Dermal Matrix on patients requiring skin grafts for wound healing. It aims to determine how quickly Cohealyx can create tissue that supports wound closure after surgical excision.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: CohealyxExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Avita Medical

Lead Sponsor

Trials
18
Recruited
720+

Citations

Study Details | NCT06787690 | Multicenter Single-arm Trial ...The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients ...
Cohealyx Dermal MatrixCohealyx Collagen Dermal Matrix is bioengineered for full-thickness wound management. Balanced using proprietary TetraPure Technology.
Avita Medical's Cohealyx Study: A Potential Game ...' The study aims to evaluate the effectiveness of Cohealyx Collagen Matrix in treating full thickness wounds that require skin grafts, focusing ...
Bovine Dermal Collagen Matrix Promotes Vascularized ...Results. Upon application to the excised full-thickness wound bed, BDCM and ColGAG quickly absorbed the blood and exudate present in the wound. ...
U.S. FDA Clears Avita Medical's Cohealyx for Healing Full- ...Preclinical studies in porcine models demonstrated that Cohealyx generated robust tissue capable of consistently supporting a split-thickness skin graft in a ...
Cohealyx for Full Thickness WoundsThis trial is for patients with full thickness wounds needing skin grafts. They must be hospitalized within 3 days of injury, have surgery within 5 days, and ...
AVITA Medical Announces FDA 510(k) Clearance for ...Cohealyx is designed for tissue integration and revascularization to facilitate wound healing, reduce treatment timelines, and improve patient ...
Ohio State first in the world to use new wound care treatmentCohealyx TM is a collagen-based skin substitute. It's designed to stimulate skin growth and blood vessel formation in patients with full-thickness wounds.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security