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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05189743
Other study ID # 2.4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date January 31, 2021

Study information

Verified date December 2021
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Sweden Linköpings Unversity Hospital Linköping

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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