Full Thickness BurnNCT04673435
Permeaderm Versus Homograft for Full-thickness Burns
A study testing PermeaDerm for temporary coverage, FHCA for temporary coverage and PermeaDerm over autograft in people with Full Thickness Burn, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Frozen Human Cadaver Allograft (FHCA) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major storage spaces in comparison to other products. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Full Thickness Burn
- What is being tested?
- PermeaDerm for temporary coverage, FHCA for temporary coverage and PermeaDerm over autograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 31 Jul 2020
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 2 % total body surface area (TBSA) full thickness burned.
- Patients with two adjacent or body symmetrical full thickness burned areas (each ≥ 1 TBSA) and comparable in size (TBSA ± 0.5), that require debridement and autografting.
Who cannot join
- Time from injury to admission >= 5 days
- Sepsis on admission or clinically suspected infection (as per attending physician)
- Pregnancy or childbearing
- Positive HIV or hepatitis screens
- History of active malignancy
- Patients who do not require surgical debridement and autografting
- Patient with burn injuries originating from other causes (chemical, and frostbite)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of texas Medical Branch Galveston
Galveston, Texas, 77555
About this study
Official title: Biosynthetic Skin Substitute Versus Frozen Human Cadaver Allograft for Temporary Coverage of Excised Full-thickness Burn Wounds
Frozen Human Cadaver Allograft (FHCA) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major storage spaces in comparison to other products. The purpose of this study is to determine the extent to which PermeaDerm® dressing promotes wound bed maturation when used as a temporary dressing for excised full-thickness burn wounds. Efficacy and safety in promoting wound bed maturation for successive autografting will be determined through direct comparison to FHCA.
Read the detailed description
In this prospective, randomized, matched design pilot study, we aim to compare the current standard of care FHCA to PermeaDerm®.
30 patients for each study arm (n total = 60) meeting the inclusion criteria will be enrolled to randomly receive FHCA and PermeaDerm® on two adjacent or symmetric body areas.
Prior to randomization of study areas and application of study dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Percentage of graft take and wound healing after removal of the temporary wound dressings and secondary autografting (study arm 1) or after excision and direct autografting with wiedely-meshed autograft and temporary wound dressings as overlay (study arm 2) will be assessed.
Secondary outcomes will include complications such as infections, signs of rejection/non-adherence, fluid accumulation/hematoma beneath dressings and mid- and long-term clinical scar maturation, as assessed by the POSAS and objectively with the DermaLab Combo® device (Cortex Technology ApS, Hadsund, Denmark).
- Conditions
- Full Thickness Burn
- Being tested
- PermeaDerm for temporary coverage, FHCA for temporary coverage, PermeaDerm over autograft, FHCA over autograft
- Keywords
- PermeaDerm, Cadaver skin, full thickness burn, temporary coverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PermeaDerm for temporary coverageDevice
See above
FHCA for temporary coverageDevice
See above
PermeaDerm over autograftDevice
See above
FHCA over autograftDevice
see above
| Study group | Role | What they receive |
|---|---|---|
| Permeaderm as temporary coverage | Experimental | A: temporary coverage with PermeaDerm until autografting: After randomization of study site, study dressing will be applied as temporary coverage on freshly excised full-thickness burn wounds. Receives: Device: PermeaDerm for temporary coverage |
| FHCA as temporary coverage | Active comparator | B: temporary coverage with FHCA until autografting: After randomization of study site, study dressing will be applied as temporary coverage on freshly excised full-thickness burn wounds. Receives: Device: FHCA for temporary coverage |
| Permeaderm over widely meshed autograft | Experimental | C: temporary coverage of widely meshed autograft with PermeaDerm until healing occurs and PermeaDerm can remove Receives: Device: PermeaDerm over autograft |
| FHCA over widely meshed autograft | Active comparator | D: temporary coverage of widely meshed autograft with FHCA until healing occurs Receives: Device: FHCA over autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to heal
Time until study areas are 95% healed, as rated by blinded assessors based on photographs
Measured: up to 8 weeks after initial grafting
Secondary outcomes (20)
Incidence of adherence problems (Arm 2)
% of non-adherence at first dressing change
Measured: up to 21 days after initial surgery
Incidence of adherence problems (Arm 1)
% of non-adherence at first dressing change and at time of dressing removal before grafting
Measured: up to 21 days after initial surgery
Incidence of infections
Incidence of infection, defined as >10x5 bacteria/g tissue, Only taken when infection suspected.
Measured: up to 8 weeks after initial grafting
Rate of fluid/hematoma accumulation
% of fluid accumulation/hematoma formation at first dressing change
Measured: up to 21 days after initial surgery
Cost effectiveness
Price per cm square of each study dressing
Measured: Until grafting of study sites, within 21 days
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.
Measured: Assessed within 4 weeks after 95% wound healing
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.
Measured: Assessed between 3 and 9 months after initial admission
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.
Measured: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Measured: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Measured: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Viscoelasticity
Measured through negative suction and retraction time.
Measured: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Measured: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Measured: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Hydration
Measured based on skin conductance.
Measured: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Measured: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Measured: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Pigmentation
Measured based on light absorption of melanin and erythema
Measured: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Trans epithermal water loss
Measuring evaporation in g/meter square/hour
Measured: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Trans epithermal water loss
Measuring evaporation in g/meter square/hour
Measured: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Trans epithermal water loss
Measuring evaporation in g/meter square/hour
Measured: Assessed between 9-15 months after initial admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start31 Jan 2018 (estimated)
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2020 (estimated)
Why it stopped: Protocol was withdrawn and closed by IRB in April, 2018 prior to enrollment of first patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Thickness BurnStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Randomized matched design with application of both study dressings symmetrical or adjacent body sites at the same time.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673435
- Sponsor's protocol ID
- 16-0344
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: data won't be shared
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biosynthetic Skin Substitute Versus Frozen Human Cadaver Allograft for Temporary Coverage of Excised Full-thickness Burn Wounds
- ClinicalTrials.gov ID
- NCT04673435
- Acronym / sponsor ID
- 16-0344
- Conditions
- Full Thickness Burn
- Keywords
- PermeaDerm, Cadaver skin, full thickness burn, temporary coverage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol was withdrawn and closed by IRB in April, 2018 prior to enrollment of first patient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- 31 Jan 2018 (estimated)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 17 Dec 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.
Frozen Human Cadaver Allograft (FHCA) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major storage spaces in comparison to other products. The purpose of this study is to determine the extent to which PermeaDerm® dressing promotes wound bed maturation when used as a temporary dressing for excised full-thickness burn wounds. Efficacy and safety in promoting wound bed maturation for successive autografting will be determined through direct comparison to FHCA.
Detailed description
In this prospective, randomized, matched design pilot study, we aim to compare the current standard of care FHCA to PermeaDerm®.
30 patients for each study arm (n total = 60) meeting the inclusion criteria will be enrolled to randomly receive FHCA and PermeaDerm® on two adjacent or symmetric body areas.
Prior to randomization of study areas and application of study dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Percentage of graft take and wound healing after removal of the temporary wound dressings and secondary autografting (study arm 1) or after excision and direct autografting with wiedely-meshed autograft and temporary wound dressings as overlay (study arm 2) will be assessed.
Secondary outcomes will include complications such as infections, signs of rejection/non-adherence, fluid accumulation/hematoma beneath dressings and mid- and long-term clinical scar maturation, as assessed by the POSAS and objectively with the DermaLab Combo® device (Cortex Technology ApS, Hadsund, Denmark).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized matched design with application of both study dressings symmetrical or adjacent body sites at the same time.
| Arm | Type | Receives |
|---|---|---|
| Permeaderm as temporary coverage | Experimental | Device: PermeaDerm for temporary coverageA: temporary coverage with PermeaDerm until autografting: After randomization of study site, study dressing will be applied as temporary coverage on freshly excised full-thickness burn wounds. |
| FHCA as temporary coverage | Active comparator | Device: FHCA for temporary coverageB: temporary coverage with FHCA until autografting: After randomization of study site, study dressing will be applied as temporary coverage on freshly excised full-thickness burn wounds. |
| Permeaderm over widely meshed autograft | Experimental | Device: PermeaDerm over autograftC: temporary coverage of widely meshed autograft with PermeaDerm until healing occurs and PermeaDerm can remove |
| FHCA over widely meshed autograft | Active comparator | Device: FHCA over autograftD: temporary coverage of widely meshed autograft with FHCA until healing occurs |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 2 % total body surface area (TBSA) full thickness burned.
- Patients with two adjacent or body symmetrical full thickness burned areas (each ≥ 1 TBSA) and comparable in size (TBSA ± 0.5), that require debridement and autografting.
Key exclusion criteria (7 listed)
- Time from injury to admission >= 5 days
- Sepsis on admission or clinically suspected infection (as per attending physician)
- Pregnancy or childbearing
- Positive HIV or hepatitis screens
- History of active 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 |
|---|---|---|
| PermeaDerm for temporary coverageSee above | Device | Permeaderm as temporary coverage |
| FHCA for temporary coverageSee above | Device | FHCA as temporary coverage |
| PermeaDerm over autograftSee above | Device | Permeaderm over widely meshed autograft |
| FHCA over autograftsee above | Device | FHCA over widely meshed autograft |
Primary outcome
Time to heal
Time frame: up to 8 weeks after initial grafting
Time until study areas are 95% healed, as rated by blinded assessors based on photographs
20 secondary outcomes
Incidence of adherence problems (Arm 2)
Time frame: up to 21 days after initial surgery
Incidence of adherence problems (Arm 1)
Time frame: up to 21 days after initial surgery
Incidence of infections
Time frame: up to 8 weeks after initial grafting
Rate of fluid/hematoma accumulation
Time frame: up to 21 days after initial surgery
Cost effectiveness
Time frame: Until grafting of study sites, within 21 days
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Time frame: Assessed within 4 weeks after 95% wound healing
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Time frame: Assessed between 3 and 9 months after initial admission
Scar assessment with Patient and Observer Assessment Scale (POSAS)
Time frame: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Viscoelasticity
Time frame: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Viscoelasticity
Time frame: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Viscoelasticity
Time frame: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Hydration
Time frame: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Hydration
Time frame: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Hydration
Time frame: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Pigmentation
Time frame: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Pigmentation
Time frame: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Pigmentation
Time frame: Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Trans epithermal water loss
Time frame: Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Trans epithermal water loss
Time frame: Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Trans epithermal water loss
Time frame: Assessed between 9-15 months after initial admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No. data won't be shared
Related trials for Full Thickness Burn
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
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.
David N Herndon, MD principal investigator
The University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PermeaDerm for temporary coverage, FHCA for temporary coverage and PermeaDerm over autograft in people with Full Thickness Burn, run by The University of Texas Medical Branch, Galveston 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 17 Dec 2020. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 to heal (time frame: up to 8 weeks after initial grafting). 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 17 Dec 2020.