BurnCohealyx INCT06787690
Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds
A study testing Cohealyx in people with Burn and Trauma Wound, run by Avita Medical at 18 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burn, Trauma Wound, Full Thickness Wounds
- What is being tested?
- Cohealyx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 18 sitesUnited States
- Study dates
- 15 May 2025to 12 Aug 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all the following criteria to be eligible for participation:
- The patient has a staged surgical procedure planned that requires autografting for treatment of a full thickness wound.
- The patient is hospitalized within 3 days of injury.
- The surgical excision occurs within 5 days post-injury.
- The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
- The patient (or parent/guardian/legally authorized representative) agrees to abstain from any other treatment of the study area or enrollment in another interventional clinical trial for the duration of his/her participation in the study (26 weeks post-autografting).
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- In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
- Understand the full nature and purpose of the study, including possible risks and adverse events,
- Understand instructions, and
- Provide voluntary written informed consent
Who cannot join
- Subjects who meet any of the following criteria are not eligible for participation:
- Clinical signs of wound infection at study area.
- The patient has a medical condition, is using medications or receiving treatments (e.g., immune deficiency) that may compromise patient safety or the trial evaluations or objectives.
- The patient is unable to understand English or Spanish.
- The patient has a known hypersensitivity to bovine-derived collagen, porcine, or aloe vera materials.
- Presence of a medical condition where the patient's life expectancy is less than 1 year (e.g., malignancy).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Akron Children's Hospital
Akron, Ohio, 44308
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Ohio State University
Columbus, Ohio, 43210
JPS Health Network
Fort Worth, Texas, 76104
Univ of Iowa
Iowa City, Iowa, 52242
The University of Kansas Health
Kansas City, Kansas, 66160
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
University of Louisville
Louisville, Kentucky, 40202
Texas Tech University
Lubbock, Texas, 79430
University of South Alabama
Mobile, Alabama, 36604
University Medical Center
New Orleans, Louisiana, 70112
Valleywise Health
Phoenix, Arizona, 85008
Chippenham Hospital
Richmond, Virginia, 23225
University of Rochester
Rochester, New York, 14642
Mercy Hospital Springfield
Springfield, Missouri, 65804
University of Arizona
Tucson, Arizona, 85724
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Prospective Multicenter Single-arm Clinical Study to Investigate Clinical Outcomes When Cohealyx™ is Used for the Management of Full Thickness Wounds Post-surgical Excision
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.
Read the detailed description
This is a prospective single-arm post-market multicenter study to evaluate clinical outcomes of Cohealyx when used to manage full thickness wounds post-surgical excision. A systematic literature review and meta-analysis were conducted to establish a performance goal for the primary effectiveness endpoint (time to autografting).
Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury.
Following placement of Cohealyx, investigators will evaluate the wound every 3 days. Once Cohealyx has successfully integrated into the wound bed, as indicated by a robust vascularized tissue bed, the wound bed will be prepared and autografted per the investigative site's standard of care.
The study area will be evaluated with respect to Cohealyx integration, time to autografting, autograft take, healing, and safety-related adverse events.
Post-autografting, subjects will be followed for 6.5 months. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas as well as any donor sites dressed in PermeaDerm will be documented using digital photography.
- Conditions
- Burn, Trauma Wound, Full Thickness Wounds, Surgical Wound
- Being tested
- Cohealyx
- Medical subject headings
- Burns, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohealyxDevice
Cohealyx application, followed by autologous split-thickness skin graft
| Study group | Role | What they receive |
|---|---|---|
| Cohealyx | Experimental | Cohealyx application post surgical excision Receives: Device: Cohealyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for Cohealyx to generate tissue capable of supporting definitive closure
Defined as the number of days from placement of Cohealyx until placement of an autologous split-thickness skin graft
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start15 May 2025
- Primary completion10 Feb 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avita Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787690
- Sponsor's protocol ID
- CTP011
- Acronym
- Cohealyx I
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Single-arm Clinical Study to Investigate Clinical Outcomes When Cohealyx™ is Used for the Management of Full Thickness Wounds Post-surgical Excision
- ClinicalTrials.gov ID
- NCT06787690
- Acronym / sponsor ID
- Cohealyx I / CTP011
- Conditions
- Burn, Trauma Wound, Full Thickness Wounds, Surgical Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Avita MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 May 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 22 Jan 2025 (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 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.
Detailed description
This is a prospective single-arm post-market multicenter study to evaluate clinical outcomes of Cohealyx when used to manage full thickness wounds post-surgical excision. A systematic literature review and meta-analysis were conducted to establish a performance goal for the primary effectiveness endpoint (time to autografting).
Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury.
Following placement of Cohealyx, investigators will evaluate the wound every 3 days. Once Cohealyx has successfully integrated into the wound bed, as indicated by a robust vascularized tissue bed, the wound bed will be prepared and autografted per the investigative site's standard of care.
The study area will be evaluated with respect to Cohealyx integration, time to autografting, autograft take, healing, and safety-related adverse events.
Post-autografting, subjects will be followed for 6.5 months. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas as well as any donor sites dressed in PermeaDerm will be documented using digital photography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohealyx | Experimental | Device: CohealyxCohealyx application post surgical excision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- The patient has a staged surgical procedure planned that requires autografting for treatment of a full thickness wound.
- The patient is hospitalized within 3 days of injury.
- The surgical excision occurs within 5 days post-injury.
- The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
- The patient (or parent/guardian/legally authorized representative) agrees to abstain from any other treatment of the study area or enrollment in another interventional clinical trial for the duration of his/her participation in the study (26 weeks post-autografting).
Key exclusion criteria (6 listed)
- Clinical signs of wound infection at study area.
- The patient has a medical condition, is using medications or receiving treatments (e.g., immune deficiency) that may compromise patient safety or the trial evaluations or objectives.
- The patient is unable to understand English or Spanish.
- The patient has a known hypersensitivity to bovine-derived collagen, porcine, or aloe vera materials.
- Presence of a medical condition where the patient's life expectancy is less than 1 year (e.g., malignancy).
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 |
|---|---|---|
| CohealyxCohealyx application, followed by autologous split-thickness skin graft | Device | Cohealyx |
Primary outcome
Time for Cohealyx to generate tissue capable of supporting definitive closure
Time frame: Up to 30 days
Defined as the number of days from placement of Cohealyx until placement of an autologous split-thickness skin graft
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohealyx in people with Burn and Trauma Wound, run by Avita Medical at 18 sites 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time for Cohealyx to generate tissue capable of supporting definitive closure (time frame: Up to 30 days). 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 23 Sep 2026.