Permeaderm Versus Homograft for Full-thickness Burns

NCT04673435 | Withdrawn DMC FDA Device

• 1 other identifier: 16-0344
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Full Thickness Burn

Keywords

PermeaDerm; Cadaver skin; full thickness burn; temporary coverage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Incidence of adherence problems (Arm 2)

  up to 21 days after initial surgery

• Incidence of adherence problems (Arm 1)

  up to 21 days after initial surgery

• Incidence of infections

  up to 8 weeks after initial grafting

• Rate of fluid/hematoma accumulation

  up to 21 days after initial surgery

• Cost effectiveness

  Until grafting of study sites, within 21 days

Study Arms (4)

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.

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.

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

Device: PermeaDerm over autograft

FHCA over widely meshed autograft

ACTIVE COMPARATOR

D: temporary coverage of widely meshed autograft with FHCA until healing occurs

Device: FHCA over autograft

Interventions

PermeaDerm for temporary coverage DEVICE

See above

Permeaderm as temporary coverage

FHCA for temporary coverage DEVICE

See above

FHCA as temporary coverage

PermeaDerm over autograft DEVICE

See above

Permeaderm over widely meshed autograft

FHCA over autograft DEVICE

see above

FHCA over widely meshed autograft

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Shriners Hospitals for Children: collaborator

Study Sites (1)

University of texas Medical Branch Galveston

Galveston, Texas, 77555, United States

Location

Study Officials

• David N Herndon, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors (healing time and scar assessments) are blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized matched design with application of both study dressings symmetrical or adjacent body sites at the same time.

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: January 31, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)