Permeaderm Versus Homograft for Full-thickness Burns

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.

Study Overview

• Status: Withdrawn
• Conditions: Full Thickness Burn
• Intervention / Treatment: Device: PermeaDerm for temporary coverage; Device: FHCA for temporary coverage; Device: PermeaDerm over autograft; Device: FHCA over autograft

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch Galveston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to heal	Time until study areas are 95% healed, as rated by blinded assessors based on photographs	up to 8 weeks after initial grafting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adherence problems (Arm 2)	% of non-adherence at first dressing change	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	up to 21 days after initial surgery
Incidence of infections	Incidence of infection, defined as >10x5 bacteria/g tissue, Only taken when infection suspected.	up to 8 weeks after initial grafting
Rate of fluid/hematoma accumulation	% of fluid accumulation/hematoma formation at first dressing change	up to 21 days after initial surgery
Cost effectiveness	Price per cm square of each study dressing	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.	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.	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.	Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Viscoelasticity	Measured through negative suction and retraction time.	Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Viscoelasticity	Measured through negative suction and retraction time.	Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Viscoelasticity	Measured through negative suction and retraction time.	Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Hydration	Measured based on skin conductance.	Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Hydration	Measured based on skin conductance.	Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Hydration	Measured based on skin conductance.	Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Pigmentation	Measured based on light absorption of melanin and erythema	Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Pigmentation	Measured based on light absorption of melanin and erythema	Assessed between 3 and 9 months after initial admission
Scarring with DermaLab Combo device: Pigmentation	Measured based on light absorption of melanin and erythema	Assessed between 9-15 months after initial admission
Scarring with DermaLab Combo device: Trans epithermal water loss	Measuring evaporation in g/meter square/hour	Assessed within 4 weeks after 95% wound healing
Scarring with DermaLab Combo device: Trans epithermal water loss	Measuring evaporation in g/meter square/hour	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	Assessed between 9-15 months after initial admission

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Shriners Hospitals for Children
• Investigators: Principal Investigator: David N Herndon, MD, The University of Texas Medical Branch, Galveston

Study record dates

Study Major Dates

• Study Start (Anticipated): January 31, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: PermeaDerm; Cadaver skin; full thickness burn; temporary coverage
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 16-0344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: data won't be shared

Drug and device information, study documents

• 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