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Completed

NCT Number: NCT05189743

The Dermisgraft Epithelialization and Late Scar Healing

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköpings Unversity Hospital

Linköping, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin transplantation to heal burn injuries

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.

Primary outcomes

  1. Healing time

    Time frame: 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.

  2. Aesthetic outcome

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jan 12, 2022
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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