The Dermisgraft Epithelialization and Late Scar Healing

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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Procedure: Skin transplantation to heal burn injuries

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Linköpings Unversity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermis graft	Procedure: 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.
Experimental: STSG	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No