The Dermisgraft Epithelialization and Late Scar Healing

Study Overview
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Brief Summary
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Study Synopsis Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring. Design; the study is a prospective, controlled clinical multicenter trial. Study population; Atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover. Time plan; Enrollment will continue until atleast 20 patients have been included and completed the study.

Detailed Description
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Background: Donor site morbidity is a major concern such as wound healing disturbances, hypertrophic scarring and hypo-/hyperpigmentation. The dermal graft technique is an alternative to the standard split-thickness skin graft (STSG) technique to minimize donor site morbidity. Immediate cover of the donor site after harvest leaving a non-exposed wound is a big advantage. The aim of the study was to compare the functional and aesthetic outcome between two treatment methods (dermal graft with STSG). Methods: From February 2017 to December 2020, 21 patients received a dermis graft and a regular split-thickness skin graft in a prospective randomized study design. The recipient and the donor site were compared separately regarding healing time, scarring and patient subjective satisfaction. All sites (both donor and recipient) were analyzed histologically regarding remodeling and scar formation.

Official Title
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A Prospective Multi-centre Randomised Study for Treatment of Burns With Dermis Graft or Split-thickness Skin Auto-graft.

Conditions
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Burns

Intervention / Treatment
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* Procedure: Skin transplantation to heal burn injuries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Thermal & chemical burns < 30 % TBSA Males & females between 18-80 years old At least one coherent full thickness wound measuring 15 x 7.5 cm A minimal of 15 x 7.5 cm coherent undamaged skin located at frontal or lateral side of one of the thighs for graft harvest. Exclusion Criteria: Patients with severe cutaneous trauma at the same site as the burn injury Previous burns at the treatment site Severe cognitive dysfunction or psychiatric disorder Chronic skin disorder Chronic use of systemic or local corticosteroid Chronic use of anticoagulants or platelets Autoimmune disease Active hepatitis Full thickness burns of head, genitalia, axilla or upper third of medial upper arm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermis graft<br> | Procedure: Skin transplantation to heal burn injuries<br>* The study compare two different treatment modalities, STSG (split-thickness skin graft) versus dermis graft after excision of devitalized/necrotic tissue. A dermatome will be used for graft harvest.<br>|
| Experimental: STSG<br> | Procedure: Skin transplantation to heal burn injuries<br>* The study compare two different treatment modalities, STSG (split-thickness skin graft) versus dermis graft after excision of devitalized/necrotic tissue. A dermatome will be used for graft harvest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing time | Recipient sites are to be assessed regarding healing (re-epithelization) at each site (donor respective recipient). Healing will be assesed in days after surgery. | 4 weeks | 
| Aesthetic outcome | The aesthetic appereance regarding scarring will be assessed. A MPA580 cutometer will asses the viscoelasticity in the skin and POSAS will asses the appereance of the scar objectively as subjectively. R0 and R2 will be used as variables evaluating firmness and elasticity. POSAS will be analysed accoring to a scoring system (0-10 and 0-60). | 12 months |