BurnsPhase 4NCT04589442
Microsurfaced Grafts in Deep Burn Wounds
A Phase 4 study testing Split thickness skin graft and microsurfaced split thickness skin graft in people with Burns and Wound Heal, run by CellTherX at 1 site in United States.
Trial summary
This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Burns, Wound Heal
- What is being tested?
- Split thickness skin graft and microsurfaced split thickness skin graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to Dec 2021
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent by patient or Legally Authorized Representative (LAR)
- Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn
- Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2 study burn sites large enough to each accommodate control and microsurfaced cadaveric graft, respectively at minimum 4 cm2.
- Total Body Surface Area burned (TBSA) total ≤30 %
- Admission within 72 hours of burn injury
- Non-infected wound as diagnosed by the attending physician upon admission
- Treated as an outpatient or in an observational setting
- 21 years of age or older
Who cannot join
- Burns involving the face
- Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
- Admission time greater than 72 hours after the injury
- Wounds noted to be infected at admission
- Is pregnant or plans to become pregnant
- Is nursing or actively lactating
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- Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
- Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's participation in the study protocol or record study materials
- Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Joseph M Still Research Foundation
Augusta, Georgia, 30909
Joan Wilson, 706-364-2966, joan.wilson@jmsresearchfoundation.org
Claus Brandigi, MD
About this study
Official title: A Prospective, Randomized Study to Evaluate the Effectiveness of Microsurfaced vs Control Cadaveric Decellularized Grafts to Establish Wound Bed Preparedness in Deep Partial and Full Thickness Burn Wounds
This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.
- Conditions
- Burns, Wound Heal
- Being tested
- Split thickness skin graft, microsurfaced split thickness skin graft
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split thickness skin graftBiological
standard of care graft
microsurfaced split thickness skin graftBiological
standard of care graft that has been microsurfaced
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Dermal Graft | Active comparator | Standard of care cryopreserved cadaveric split thickness skin grafts Receives: Biological: Split thickness skin graft |
| Standard of Care Dermal Graft - Microsurfaced | Experimental | Microsurfaced cryopreserved cadaveric split thickness skin grafts Receives: Biological: microsurfaced split thickness skin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound bed prep
To compare wound bed preparedness/time to autograft in deep-partial and full thickness burns and burn wound healing in partial thickness burns in burn sites treated with Microsurfaced vs Control cadaveric graft-treated groups through 6 weeks post initial injury.
Measured: 6 week
Secondary outcomes (6)
Infection
Incidence of Infection at each treatment study visit
Measured: Through 12 months
Autograft take
Autograft take will be documented as a percentage of the graft by the physician
Measured: 2 weeks
Tissue oxygenation
Tissue oxygenation will be assessed using hyperspectral imaging
Measured: 2 weeks
Tissue Oxygenation
Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline.
Measured: 6 weeks
Scar assessment
Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS)
Measured: 3, 6, 9, 12 months
Tissue oxygenation
Tissue oxygenation will be assessed using hyperspectral imaging
Measured: 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start4 Jan 2021
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellTherX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Brandigi, MD, Principal investigator, Joseph M Still Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589442
- Sponsor's protocol ID
- MB2019-01
- Status last verified
- Jan 2021
- First submitted
- 5 Oct 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study to Evaluate the Effectiveness of Microsurfaced vs Control Cadaveric Decellularized Grafts to Establish Wound Bed Preparedness in Deep Partial and Full Thickness Burn Wounds
- ClinicalTrials.gov ID
- NCT04589442
- Acronym / sponsor ID
- MB2019-01
- Conditions
- Burns, Wound Heal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CellTherXIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Dermal Graft | Active comparator | Biological: Split thickness skin graftStandard of care cryopreserved cadaveric split thickness skin grafts |
| Standard of Care Dermal Graft - Microsurfaced | Experimental | Biological: microsurfaced split thickness skin graftMicrosurfaced cryopreserved cadaveric split thickness skin grafts |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent by patient or Legally Authorized Representative (LAR)
- Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn
- Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2 study burn sites large enough to each accommodate control and microsurfaced cadaveric graft, respectively at minimum 4 cm2.
- Total Body Surface Area burned (TBSA) total ≤30 %
- Admission within 72 hours of burn injury
Key exclusion criteria (9 listed)
- Burns involving the face
- Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
- Admission time greater than 72 hours after the injury
- Wounds noted to be infected at admission
- Is pregnant or plans to become pregnant
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 |
|---|---|---|
| Split thickness skin graftstandard of care graft | Biological | Standard of Care Dermal Graft |
| microsurfaced split thickness skin graftstandard of care graft that has been microsurfaced | Biological | Standard of Care Dermal Graft - Microsurfaced |
Primary outcome
Wound bed prep
Time frame: 6 week
To compare wound bed preparedness/time to autograft in deep-partial and full thickness burns and burn wound healing in partial thickness burns in burn sites treated with Microsurfaced vs Control cadaveric graft-treated groups through 6 weeks post initial injury.
6 secondary outcomes
Infection
Time frame: Through 12 months
Autograft take
Time frame: 2 weeks
Tissue oxygenation
Time frame: 2 weeks
Tissue Oxygenation
Time frame: 6 weeks
Scar assessment
Time frame: 3, 6, 9, 12 months
Tissue oxygenation
Time frame: 3, 6, 9, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- 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.
Claus Brandigi, MD principal investigator
Joseph M Still Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Split thickness skin graft and microsurfaced split thickness skin graft in people with Burns and Wound Heal, run by CellTherX at 1 site 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Wilson (706-364-2966, joan.wilson@jmsreserachfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound bed prep (time frame: 6 week). 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 15 Jan 2021.