Clinical and Histological Study of a Novel Dermal Substitute
ConditionSkin Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-75
SponsorUniversity Children's Hospital, Zurich
About this trial
The goal of this observational study is to compare a novel dermal substitute to a the current standard procedure in the treatment of full thickness skin defects.
The main questions aim to answer are:
• Is the skin elasticity treated with the novel dermal substitute better than the skin elasticity treated with the current standard procedure Participants skin elasticity will be measured by Cutometer® MPA-580 assessment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 1 to 75 years
Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans or similar condition
Reconstructive cases (elective surgery): e.g. scar formation after burn injury, giant congenital nevus, defect after removal of skin tumor, skin defect due to other surgical procedures
Documented medical treatment decision of covering the full-thickness skin defects with either the two-step BTM/STSG procedure or with STSG alone or by using both techniques on different wound areas
Disqualifiers
Infected wounds needing surgical procedure other than a dermal template
Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin disease, any kind of congenital defect of metabolism including diabetes)
Previous enrolment of the patient into the current study
Adolescent/Adult patients or in case of children their parents/legal representatives unable to comply with the study protocol
Trial population
The project population will consist of children and adults that received surgical coverage of full-thickness skin defects either the two-step BTM/STSG procedure or with STSG alone under routine conditions.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard of care
Other interventionStandard of care
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: NovoSorb® BTM and STSG1 intervention
Group B: STSG alone1 intervention
Trial outcomes
Primary outcomes
1
Skin elasticity after 1year post-transplantation
Comparison of skin elasticity of treated skin versus adjacent normal skin
Time frame
1 year post-transplantationSecondary outcomes
1
Histological staining
Histological characterisation of epidermal and dermal components
Time frame
within 1 year after skin transplantation2
Skin color assessment
Changes in skin color
Time frame
within 1 year after skin transplantation3
Photographical assessment
Changes in graft-size
Time frame
within 1 year after skin transplantation4
Change of quality of life within one year after skin transplantation
Quality of life assessed with standard EuroQoL questionnaire
Time frame
within 1 year after skin transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Children's Hospital, Zurich
Lead sponsor
University of Zurich
Collaborator
Kantonsspital Aarau
Collaborator
Kantonsspital Winterthur KSW
Collaborator
Source ClinicalTrials.gov