NCT05189743

The Dermisgraft Epithelialization and Late Scar Healing

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Burns

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2020-12-31
• Completion: 2021-01-31
• First posted: 2022-01-12
• Last updated: 2022-01-12

Locations

1 site across 1 country: Sweden