The Dermisgraft Epithelialization and Late Scar Healing

NCT05189743 | Completed

• 1 other identifier: 2.4
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Dermis graft

EXPERIMENTAL

Procedure: Skin transplantation to heal burn injuries

STSG

EXPERIMENTAL

Procedure: Skin transplantation to heal burn injuries

Interventions

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.

Dermis graft; STSG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Linköpings Unversity Hospital

Linköping, Sweden

Location

Related Publications (1)

• Dogan S, Elmasry M, El-Serafi A, Sjoberg F, Vuola J, Kankuri E, Grigoriadi MP, Valtonen J, Abdelrahman I, Steinvall I, Karlsson M, Olofsson P, Lindford A. A prospective dual-centre intra-individual controlled study for the treatment of burns comparing dermis graft with split-thickness skin auto-graft. Sci Rep. 2022 Dec 15;12(1):21666. doi: 10.1038/s41598-022-25346-4.

  PMID: 36522434 DERIVED

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: January 12, 2022
• Study Start: February 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: January 12, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SE (1)