The Dermisgraft Epithelialization and Late Scar Healing

University Hospital, Linkoeping

Status

Completed

Conditions

Burns

Treatments

Procedure: Skin transplantation to heal burn injuries

Study type

Interventional

Funder types

Other

Identifiers

NCT05189743

2.4

Details and patient eligibility

About

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.

Full description

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.

Enrollment

23 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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