The Dermisgraft Epithelialization and Late Scar Healing

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

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2021-01-31

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.

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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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dermis graft

Group Type EXPERIMENTAL

Skin transplantation to heal burn injuries

Intervention Type PROCEDURE

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.

STSG

Group Type EXPERIMENTAL

Skin transplantation to heal burn injuries

Intervention Type PROCEDURE

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.

Interventions

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Skin transplantation to heal burn injuries

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes