Skin Transplantation
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.
Interventions
OTHERStandard of care
Standard of care
Sponsors
University Children's Hospital, Zurich
University of Zurich
Kantonsspital Aarau
Kantonsspital Winterthur KSW
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: 1 to 75 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 * Pregnant or breast feeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin elasticity after 1year post-transplantation | 1 year post-transplantation | Comparison of skin elasticity of treated skin versus adjacent normal skin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological staining | within 1 year after skin transplantation | Histological characterisation of epidermal and dermal components |
| Skin color assessment | within 1 year after skin transplantation | Changes in skin color |
| Photographical assessment | within 1 year after skin transplantation | Changes in graft-size |
| Change of quality of life within one year after skin transplantation | within 1 year after skin transplantation | Quality of life assessed with standard EuroQoL questionnaire |
| Immunohistochemical analyses | 14-21 days after BTM transplantation | Histological characterisation of mature BTM |
Countries
Switzerland
Contacts
CONTACTSophie Böttcher, MD
CONTACTVivienne Woodtli, dipl. med.
PRINCIPAL_INVESTIGATORSophie Böttcher, MD
University Children's Hospital, Zurich
Outcome results
None listed