Cohealyx for Full Thickness Wounds
(Cohealyx I Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Avita Medical

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

+5 more

Trial Timeline

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)

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: CohealyxExperimental Treatment1 Intervention

Cohealyx application post surgical excision