An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Wound Healing; Scar Formation

Treatments: Device: Wound coverage by acellular skin substitute; Device: Autologous skin

Study type: Interventional

Funder types: Other

Identifiers

NCT01454310

SUPRA-VS-STSG-2010

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Acellular skin substitute

Experimental group

Treatment:

Device: Wound coverage by acellular skin substitute

Autologous skin graft

Active Comparator group

Treatment:

Device: Autologous skin