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Permeaderm Versus Homograft for Full-thickness Burns

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ClinicalTrials.gov Identifier: NCT04673435
Recruitment Status : Withdrawn (Protocol was withdrawn and closed by IRB in April, 2018 prior to enrollment of first patient)
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Full Thickness Burn Device: PermeaDerm for temporary coverage Device: FHCA for temporary coverage Device: PermeaDerm over autograft Device: FHCA over autograft Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized matched design with application of both study dressings symmetrical or adjacent body sites at the same time.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors (healing time and scar assessments) are blinded.
Primary Purpose: Treatment
Official Title: Biosynthetic Skin Substitute Versus Frozen Human Cadaver Allograft for Temporary Coverage of Excised Full-thickness Burn Wounds
Estimated Study Start Date : January 31, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Permeaderm as temporary coverage
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.
Device: PermeaDerm for temporary coverage
See above

Active Comparator: FHCA as temporary coverage
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.
Device: FHCA for temporary coverage
See above

Experimental: Permeaderm over widely meshed autograft
C: temporary coverage of widely meshed autograft with PermeaDerm until healing occurs and PermeaDerm can remove
Device: PermeaDerm over autograft
See above

Active Comparator: FHCA over widely meshed autograft
D: temporary coverage of widely meshed autograft with FHCA until healing occurs
Device: FHCA over autograft
see above




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of adherence problems (Arm 2) [ Time Frame: up to 21 days after initial surgery ]
    % of non-adherence at first dressing change

  2. Incidence of adherence problems (Arm 1) [ Time Frame: up to 21 days after initial surgery ]
    % of non-adherence at first dressing change and at time of dressing removal before grafting

  3. Incidence of infections [ Time Frame: up to 8 weeks after initial grafting ]
    Incidence of infection, defined as >10x5 bacteria/g tissue, Only taken when infection suspected.

  4. Rate of fluid/hematoma accumulation [ Time Frame: up to 21 days after initial surgery ]
    % of fluid accumulation/hematoma formation at first dressing change

  5. Cost effectiveness [ Time Frame: Until grafting of study sites, within 21 days ]
    Price per cm square of each study dressing

  6. Scar assessment with Patient and Observer Assessment Scale (POSAS) [ Time Frame: Assessed within 4 weeks after 95% wound healing ]
    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.

  7. Scar assessment with Patient and Observer Assessment Scale (POSAS) [ Time Frame: Assessed between 3 and 9 months after initial admission ]
    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.

  8. Scar assessment with Patient and Observer Assessment Scale (POSAS) [ Time Frame: Assessed between 9-15 months after initial admission ]
    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.

  9. Scarring with DermaLab Combo device: Viscoelasticity [ Time Frame: Assessed within 4 weeks after 95% wound healing ]
    Measured through negative suction and retraction time.

  10. Scarring with DermaLab Combo device: Viscoelasticity [ Time Frame: Assessed between 3 and 9 months after initial admission ]
    Measured through negative suction and retraction time.

  11. Scarring with DermaLab Combo device: Viscoelasticity [ Time Frame: Assessed between 9-15 months after initial admission ]
    Measured through negative suction and retraction time.

  12. Scarring with DermaLab Combo device: Hydration [ Time Frame: Assessed within 4 weeks after 95% wound healing ]
    Measured based on skin conductance.

  13. Scarring with DermaLab Combo device: Hydration [ Time Frame: Assessed between 3 and 9 months after initial admission ]
    Measured based on skin conductance.

  14. Scarring with DermaLab Combo device: Hydration [ Time Frame: Assessed between 9-15 months after initial admission ]
    Measured based on skin conductance.

  15. Scarring with DermaLab Combo device: Pigmentation [ Time Frame: Assessed within 4 weeks after 95% wound healing ]
    Measured based on light absorption of melanin and erythema

  16. Scarring with DermaLab Combo device: Pigmentation [ Time Frame: Assessed between 3 and 9 months after initial admission ]
    Measured based on light absorption of melanin and erythema

  17. Scarring with DermaLab Combo device: Pigmentation [ Time Frame: Assessed between 9-15 months after initial admission ]
    Measured based on light absorption of melanin and erythema

  18. Scarring with DermaLab Combo device: Trans epithermal water loss [ Time Frame: Assessed within 4 weeks after 95% wound healing ]
    Measuring evaporation in g/meter square/hour

  19. Scarring with DermaLab Combo device: Trans epithermal water loss [ Time Frame: Assessed between 3 and 9 months after initial admission ]
    Measuring evaporation in g/meter square/hour

  20. Scarring with DermaLab Combo device: Trans epithermal water loss [ Time Frame: Assessed between 9-15 months after initial admission ]
    Measuring evaporation in g/meter square/hour



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673435


Locations
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United States, Texas
University of texas Medical Branch Galveston
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Shriners Hospitals for Children
Investigators
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Principal Investigator: David N Herndon, MD The University of Texas Medical Branch, Galveston
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT04673435    
Other Study ID Numbers: 16-0344
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data won't be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The University of Texas Medical Branch, Galveston:
PermeaDerm
Cadaver skin
full thickness burn
temporary coverage
Additional relevant MeSH terms:
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Burns
Wounds and Injuries