An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01454310

Enrollment

Registered

2011-10-19

Start date

2010-11-30

Completion date

2011-09-30

Last updated

2011-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar Formation, Wound Healing

Keywords

Skin substitutes, Split-thickness skin graft, Burn wound, Scar formation, Skin quality

Brief summary

The purpose of the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for another additional option of wound coverage in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial skin substitute is at least not inferior to autologous skin grafts.

Interventions

DEVICEWound coverage by acellular skin substitute

Burn wounds are covered by an acellular skin substitute and remains 10-14 days that peals away in line with re-epithelialisation

DEVICEAutologous skin

Matched burn wound is covered by autologous skin after tangential excision.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients older than 18 years of age * verified deep partial-thickness burns * early tangential excision of burn wound (3-5 days after trauma)

Exclusion criteria

* Pregnancy * ABSI-Score \>13 * Active tumor or immune-mediated disease * Patient refusal

Design outcomes

Primary

Measure	Time frame	Description
Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin	1 year	Time to complete re-epithelialisation measured in days after surgery

Secondary

Measure	Time frame	Description
Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin	1 year	Quality of the skin is measured two-fold: 1. Subjective scar scors: Vancouver Scar Scale, Patient and Observer Scar Scale 2. Objective scar evaluation by a non-invasive suction device, that measures viscoelastic parameter.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026