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Permeaderm Versus Homograft for Full-thickness Burns

NCT04673435 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-12-17

No results posted yet for this study

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

Interventions

DEVICE

PermeaDerm for temporary coverage

See above

DEVICE

FHCA for temporary coverage

See above

DEVICE

PermeaDerm over autograft

See above

DEVICE

FHCA over autograft

see above

Sponsors & Collaborators

  • Shriners Hospitals for Children

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • David N Herndon, MD · The University of Texas Medical Branch, Galveston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2019-07-31
Completion
2020-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673435 on ClinicalTrials.gov