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An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

NCT ID: NCT01454310

Last Updated: 2011-10-19

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Wound Healing Scar Formation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acellular skin substitute

Group Type EXPERIMENTAL

Wound coverage by acellular skin substitute

Intervention Type DEVICE

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

Autologous skin graft

Group Type ACTIVE_COMPARATOR

Autologous skin

Intervention Type DEVICE

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

Interventions

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Wound 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

Intervention Type DEVICE

Autologous skin

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

Intervention Type DEVICE

Other Intervention Names

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Suprathel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Harald Franz Selig

MD, research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars P Kamolz, MD, PhD, MSc

Role: STUDY_CHAIR

Medical University of Vienna

Maike Keck, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Plastic and Reconstructive Surgery

Locations

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Medical University of Vienna, Burn Center, Department of Plastic and Reconstructive Surgery

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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Uhlig C, Rapp M, Hartmann B, Hierlemann H, Planck H, Dittel KK. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. Burns. 2007 Mar;33(2):221-9. doi: 10.1016/j.burns.2006.04.024. Epub 2006 Nov 2.

Reference Type BACKGROUND
PMID: 17084030 (View on PubMed)

Other Identifiers

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SUPRA-VS-STSG-2010

Identifier Type: -

Identifier Source: org_study_id