Linköpings Unversity Hospital
Linköping, Sweden
NCT Number: NCT05189743
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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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Linköping, Sweden
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
University Hospital, Linkoeping
Other
A Prospective Multi-centre Randomised Study for Treatment of Burns With Dermis Graft or Split-thickness Skin Auto-graft.
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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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