Surgical WoundNCT06750809
Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds
A study testing PermeaDerm Biosynthetic Wound Matrix and Frozen Human Cadaveric Allograft (FHCA) in people with Surgical Wound and Trauma Wound, run by Avita Medical at 13 sites in United States.
Trial summary
The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Wound, Trauma Wound, Autografts
- What is being tested?
- PermeaDerm Biosynthetic Wound Matrix and Frozen Human Cadaveric Allograft (FHCA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 13 sitesUnited States
- Study dates
- 21 Feb 2025to 8 May 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's wound requires temporary dressing coverage after surgical excision and prior to autografting.
- The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA).
- The study area is a contiguous area. If the patient has other areas (non-study treatment area) that require temporary dressing, these areas must also be dressed according to the randomization.
- The patient is hospitalized within 3 days of injury.
- The surgical excision occurs within 5 days post-injury.
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- 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 (8 weeks post-autografting).
- 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:
- The study area has received prior surgical intervention.
- The patient is currently using medications or treatments such as systemic corticosteroids, chemotherapy, or immunosuppressants, that in the investigator's opinion may compromise patient safety or trial objectives.
- Clinical signs of wound infection at study area that in the investigator's opinion may compromise patient safety or trial objectives.
- The patient has any of the following
- morbid obesity (BMI >40),
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- immunodeficiency,
- venous insufficiency/PVD of the lower extremities (when study area is also in this location),
- chronic malnourishment,
- inhalation injury (>Grade 1 based on AIS grading scale),
- current abuser of alcohol and/or illicit drugs based upon medical history and/or lab results,
- diabetes mellitus with HbA1c >9.0%, and/or
- advanced renal disease (eGFR <59) or liver disease (LFTs >2.5 times the upper limit).
- The patient has any another condition, that in the investigator's opinion may compromise patient safety or the trial objectives.
- The patient is unable to understand English or Spanish.
- The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft.
- The patient's life expectancy is less than 1 year.
- -
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Akron Children's Hospital
Akron, Ohio, 44308
Grady Memorial
Atlanta, Georgia, 30303
Ohio State University
Columbus, Ohio, 43210
Univ of Iowa
Iowa City, Iowa, 52242
University of Kansas
Kansas City, Kansas, 66160
Univ of Louisville Burn Center
Louisville, Kentucky, 40202
Regional One Firefighter's Burn Center
Memphis, Tennessee, 38163
University Medical Center
New Orleans, Louisiana, 70112
Valleywise Health
Phoenix, Arizona, 85008
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Rochester
Rochester, New York, 14642
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: A Prospective Post-Market Multicenter Randomized Controlled Clinical Study to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for the Management of Surgical Wounds
The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound. The researchers will review cost and other treatment results including how well both temporary dressings attach to the skin, how prepared the wound bed is to receive a skin graft, how long it takes for the skin to be ready to receive a skin graft, how well the skin graft takes and any complications. Patients will first have the temporary dressing applied to their wound, then a few days later, a skin graft will be performed. Patients will have photos of their wounds taken throughout the study including at all the clinic check-ups with the last check-up occurring about 8 weeks after treatment.
Read the detailed description
This is a prospective two-arm randomized multicenter controlled study to evaluate the clinical outcomes and economic impact of PermeaDerm and frozen human cadaveric allograft (FHCA) when they are used as a temporary dressing on surgical wounds where autografting is clinically indicated.
Patients hospitalized within 3 days of injury with a surgical wound up to 30% (inclusive) total body surface area (TBSA) will be considered for participation in this study.
Patients will undergo surgical excision within five days post-injury and will be randomly assigned (1:1) to receive PermeaDerm or FHCA as a temporary dressing. One contiguous area will be selected by the investigator as the study treatment area. Any other areas that require a temporary dressing must be dressed per the randomization.
In addition to economic impact, the two temporary dressings will be compared with respect to adherence, wound bed preparation, time to autografting, graft take, and safety-related adverse events.
Following placement of the temporary dressing, investigators will evaluate the wound every 2-3 days. The temporary dressing may be replaced, per the randomization, as clinically indicated. When the study area is ready for autografting, the temporary dressing will be removed, and the study area will be autografted per the investigative site's standard of care. The donor area(s) may be dressed in PermeaDerm or the investigative site's standard of care.
Post-autografting, subjects will be followed for 8 weeks. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas and donor sites that are dressed in PermeaDerm will be documented using digital photography.
- Conditions
- Surgical Wound, Trauma Wound, Autografts, Partial-thickness Burn, Partial Thickness Wounds
- Being tested
- PermeaDerm Biosynthetic Wound Matrix, Frozen Human Cadaveric Allograft (FHCA)
- Keywords
- Skin graft, surgical wound, trauma wound
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PermeaDerm Biosynthetic Wound MatrixDevice
Study participants randomized (1:1) to this arm will receive PermeaDerm Biosynthetic Wound Matrix prior to skin graft.
Frozen Human Cadaveric Allograft (FHCA)Device
Study participant randomized (1:1) to this arm will receive Frozen Human Cadaveric Allograft (FHCA) prior to skin graft.
| Study group | Role | What they receive |
|---|---|---|
| PermeaDerm Temporary Biosynthetic Wound Matrix | Experimental | Not described Receives: Device: PermeaDerm Biosynthetic Wound Matrix |
| Frozen Human Cadaveric Allograft (FHCA) | Experimental | Not described Receives: Device: Frozen Human Cadaveric Allograft (FHCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Cost per Total Body Surface Area (TBSA)
The reduction of cost per TBSA when PermeaDerm is used as a temporary dressing. The reduction in cost is hypothesized to be superior for PermeaDerm as compared to FHCA.
Measured: 8 weeks post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start21 Feb 2025
- Primary completion18 Mar 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06750809
- Sponsor's protocol ID
- CTP012
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2024
- 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 Post-Market Multicenter Randomized Controlled Clinical Study to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for the Management of Surgical Wounds
- ClinicalTrials.gov ID
- NCT06750809
- Acronym / sponsor ID
- CTP012
- Conditions
- Surgical Wound, Trauma Wound, Autografts, Partial-thickness Burn, Partial Thickness Wounds
- Keywords
- Skin graft, surgical wound, trauma wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Avita MedicalIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 27 Dec 2024 (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 compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound. The researchers will review cost and other treatment results including how well both temporary dressings attach to the skin, how prepared the wound bed is to receive a skin graft, how long it takes for the skin to be ready to receive a skin graft, how well the skin graft takes and any complications. Patients will first have the temporary dressing applied to their wound, then a few days later, a skin graft will be performed. Patients will have photos of their wounds taken throughout the study including at all the clinic check-ups with the last check-up occurring about 8 weeks after treatment.
Detailed description
This is a prospective two-arm randomized multicenter controlled study to evaluate the clinical outcomes and economic impact of PermeaDerm and frozen human cadaveric allograft (FHCA) when they are used as a temporary dressing on surgical wounds where autografting is clinically indicated.
Patients hospitalized within 3 days of injury with a surgical wound up to 30% (inclusive) total body surface area (TBSA) will be considered for participation in this study.
Patients will undergo surgical excision within five days post-injury and will be randomly assigned (1:1) to receive PermeaDerm or FHCA as a temporary dressing. One contiguous area will be selected by the investigator as the study treatment area. Any other areas that require a temporary dressing must be dressed per the randomization.
In addition to economic impact, the two temporary dressings will be compared with respect to adherence, wound bed preparation, time to autografting, graft take, and safety-related adverse events.
Following placement of the temporary dressing, investigators will evaluate the wound every 2-3 days. The temporary dressing may be replaced, per the randomization, as clinically indicated. When the study area is ready for autografting, the temporary dressing will be removed, and the study area will be autografted per the investigative site's standard of care. The donor area(s) may be dressed in PermeaDerm or the investigative site's standard of care.
Post-autografting, subjects will be followed for 8 weeks. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas and donor sites that are dressed in PermeaDerm will be documented using digital photography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PermeaDerm Temporary Biosynthetic Wound Matrix | Experimental | Device: PermeaDerm Biosynthetic Wound Matrix |
| Frozen Human Cadaveric Allograft (FHCA) | Experimental | Device: Frozen Human Cadaveric Allograft (FHCA) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- The patient's wound requires temporary dressing coverage after surgical excision and prior to autografting.
- The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA).
- The study area is a contiguous area. If the patient has other areas (non-study treatment area) that require temporary dressing, these areas must also be dressed according to the randomization.
- The patient is hospitalized within 3 days of injury.
- The surgical excision occurs within 5 days post-injury.
Key exclusion criteria (18 listed)
- The study area has received prior surgical intervention.
- The patient is currently using medications or treatments such as systemic corticosteroids, chemotherapy, or immunosuppressants, that in the investigator's opinion may compromise patient safety or trial objectives.
- Clinical signs of wound infection at study area that in the investigator's opinion may compromise patient safety or trial objectives.
- The patient has any of the following
- The patient has any another condition, that in the investigator's opinion may compromise patient safety or the trial objectives.
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 |
|---|---|---|
| PermeaDerm Biosynthetic Wound MatrixStudy participants randomized (1:1) to this arm will receive PermeaDerm Biosynthetic Wound Matrix prior to skin graft. | Device | PermeaDerm Temporary Biosynthetic Wound Matrix |
| Frozen Human Cadaveric Allograft (FHCA)Study participant randomized (1:1) to this arm will receive Frozen Human Cadaveric Allograft (FHCA) prior to skin graft. | Device | Frozen Human Cadaveric Allograft (FHCA) |
Primary outcome
Reduction of Cost per Total Body Surface Area (TBSA)
Time frame: 8 weeks post treatment.
The reduction of cost per TBSA when PermeaDerm is used as a temporary dressing. The reduction in cost is hypothesized to be superior for PermeaDerm as compared to FHCA.
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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PermeaDerm Biosynthetic Wound Matrix and Frozen Human Cadaveric Allograft (FHCA) in people with Surgical Wound and Trauma Wound, run by Avita Medical at 13 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 12 inclusion and 18 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 13 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?
Reduction of Cost per Total Body Surface Area (TBSA) (time frame: 8 weeks post treatment.). 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.