The Dermisgraft Epithelialization and Late Scar Healing

Not Applicable

Completed

• Conditions: Burns
• Interventions: Procedure: Skin transplantation to heal burn injuries

• Registration Number: NCT05189743
• Lead Sponsor: University Hospital, Linkoeping

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31
• Study First Submitted: 2021-11-18
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-30
• Last Update Submitted: 2021-12-30
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermis graft	Skin transplantation to heal burn injuries	-
STSG	Skin transplantation to heal burn injuries	-

Primary Outcome Measures

Name	Time	Method
Healing time	4 weeks	Recipient sites are to be assessed regarding healing (re-epithelization) at each site (donor respective recipient). Healing will be assesed in days after surgery.
Aesthetic outcome	12 months	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).

Trial Locations

Locations (1)

Linköpings Unversity Hospital; 🇸🇪 Linköping, Sweden