Clinical trial NCT06255990: Clinical and Histological Study of a Novel Dermal Substitute
Official title: Clinical and Histological Study of a Novel Dermal Substitute, NovoSorb® BTM, Used in the Treatment of Full-thickness Skin Defects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Transplantation
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2024-02-13
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: Inclusion Criteria:

* Age: 1 to 70 years
* Full-thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a STSG:

  * 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
* Informed consent by patients/parents or other legal representative

Exclusion Criteria:

* 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
* Adolescent/Adult patients or in case of children their parents/legal representatives having insufficient knowledge of local language
* Pregnant or breast feeding females

Primary outcomes:
measure: Skin elasticity after 1year post-transplantation
timeFrame: 1 year post-transplantation
Secondary outcomes:
measure: Histological staining
timeFrame: within 1 year after skin transplantation
measure: Skin color assessment
timeFrame: within 1 year after skin transplantation
measure: Photographical assessment
timeFrame: within 1 year after skin transplantation
measure: Change of quality of life within one year after skin transplantation
timeFrame: within 1 year after skin transplantation
measure: Immunohistochemical analyses
timeFrame: 14-21 days after BTM transplantation
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
state: Zurich
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Sophie Böttcher, MD
role: PRINCIPAL_INVESTIGATOR
References: