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Permeaderm Versus Homograft for Full-thickness Burns

NCT ID: NCT04673435

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-07-31

Brief Summary

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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

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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

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Full Thickness Burn

Keywords

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PermeaDerm Cadaver skin full thickness burn temporary coverage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized matched design with application of both study dressings symmetrical or adjacent body sites at the same time.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessors (healing time and scar assessments) are blinded.

Study Groups

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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.

Group Type EXPERIMENTAL

PermeaDerm for temporary coverage

Intervention Type DEVICE

See above

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.

Group Type ACTIVE_COMPARATOR

FHCA for temporary coverage

Intervention Type DEVICE

See above

Permeaderm over widely meshed autograft

C: temporary coverage of widely meshed autograft with PermeaDerm until healing occurs and PermeaDerm can remove

Group Type EXPERIMENTAL

PermeaDerm over autograft

Intervention Type DEVICE

See above

FHCA over widely meshed autograft

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

Group Type ACTIVE_COMPARATOR

FHCA over autograft

Intervention Type DEVICE

see above

Interventions

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PermeaDerm for temporary coverage

See above

Intervention Type DEVICE

FHCA for temporary coverage

See above

Intervention Type DEVICE

PermeaDerm over autograft

See above

Intervention Type DEVICE

FHCA over autograft

see above

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David N Herndon, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch, Galveston

Locations

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University of texas Medical Branch Galveston

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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16-0344

Identifier Type: -

Identifier Source: org_study_id