Clinical and Histological Study of a Novel Dermal Substitute

Skin Transplantation Clinical Trial

Official title:

Clinical and Histological Study of a Novel Dermal Substitute, NovoSorb® BTM, Used in the Treatment of Full-thickness Skin Defects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255990
• Other study ID #: 2022-00828
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: June 2027

Study information

• Verified date: February 2024
• Source: University Children's Hospital, Zurich
• Contact: Sophie Böttcher, MD
• Phone: +41442667111
• Email: sophie.boettcher[@]kispi.uzh.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Transplantation

Intervention

Other:
• Standard of care
Standard of care

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich	Zürich	Zurich
Switzerland	University Hospital Zurich	Zürich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin elasticity after 1year post-transplantation	Comparison of skin elasticity of treated skin versus adjacent normal skin	1 year post-transplantation
Secondary	Histological staining	Histological characterisation of epidermal and dermal components	within 1 year after skin transplantation
Secondary	Skin color assessment	Changes in skin color	within 1 year after skin transplantation
Secondary	Photographical assessment	Changes in graft-size	within 1 year after skin transplantation
Secondary	Change of quality of life within one year after skin transplantation	Quality of life assessed with standard EuroQoL questionnaire	within 1 year after skin transplantation
Secondary	Immunohistochemical analyses	Histological characterisation of mature BTM	14-21 days after BTM transplantation