The Dermisgraft Epithelialization and Late Scar Healing

Sponsor

University Hospital, Linkoeping (Other)

Overall Status

Completed

CT.gov ID

NCT05189743

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Procedure: Skin transplantation to heal burn injuries	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Linköpings Unversity Hospital	Linköping		Sweden

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Folke Sjoberg, Professor, University Hospital, Linkoeping

ClinicalTrials.gov Identifier:

NCT05189743

Other Study ID Numbers:

First Posted:

Jan 12, 2022

Last Update Posted:

Jan 12, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 12, 2022