Cohealyx for Full Thickness Wounds

(Cohealyx I Trial)

Recruiting at 9 trial locations

Overseen By Elizabeth Kirshner

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Avita Medical

Disqualifiers: Wound infection, Immune deficiency, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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 that require a skin graft to heal their wounds. The main question it aims to answer is how long does it take for Cohealyx to support definitive closure.

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.

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?

Group I: Cohealyx Experimental Treatment 1 Intervention

Cohealyx application post surgical excision

Who Is Running the Clinical Trial?

Avita Medical

Lead Sponsor

Trials

18

Recruited

720+