Skin TransplantationNCT06255990
Clinical and Histological Study of a Novel Dermal Substitute
An observational study of Skin Transplantation, run by University Children's Hospital, Zurich at 4 sites in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Skin Transplantation
- How many people
- 42 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 15 Jan 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
Cantonal Hospital Aarau
Aarau, Canton of Aargau, 5001
jan Plock, Prof. Dr. med., 0041628384731, plastischechirurgie@ksa.ch
- Recruiting
Cantonal Hospital Winterthur
Winterthur, Winterthur, 8400
Abdul R Jandali, Dr. med., 0041522662420, abdulrahman.jandali@ksw.ch
- Recruiting
University Children's Hospital Zurich
Zurich, Canton of Zurich, 8032
Sophie Böttcher, MD, +41442497228, sophie.boettcher@kispi.uzh.ch
Vivienne Woodtli, +41442667078, vivienne.woodtli@kispi.uzh.ch
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8090
Bong-Sung Kim, Prof., +41432538932, bong-sung.kim@usz.ch
Bong-Sung Kim, Prof.
About this study
Official title: Clinical and Histological Study of a Novel Dermal Substitute, NovoSorb® BTM, Used in the Treatment of Full-thickness Skin Defects
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.
- Conditions
- Skin Transplantation
- Being tested
- Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| NovoSorb® BTM and STSG | Full thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a split-thickness skin graft (STSG) according to clinical routine Receives: Other: Standard of care | |
| STSG alone | Full thickness skin defect qualifying for coverage with split-thickness skin graft (STSG) alone according to clinical routine Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin elasticity after 1year post-transplantation
Comparison of skin elasticity of treated skin versus adjacent normal skin
Measured: 1 year post-transplantation
Secondary outcomes (5)
Histological staining
Histological characterisation of epidermal and dermal components
Measured: within 1 year after skin transplantation
Skin color assessment
Changes in skin color
Measured: within 1 year after skin transplantation
Photographical assessment
Changes in graft-size
Measured: within 1 year after skin transplantation
Change of quality of life within one year after skin transplantation
Quality of life assessed with standard EuroQoL questionnaire
Measured: within 1 year after skin transplantation
Immunohistochemical analyses
Histological characterisation of mature BTM
Measured: 14-21 days after BTM transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start15 Jan 2024
- Primary completion1 Jun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Kantonsspital Aarau, Kantonsspital Winterthur KSW
- Responsible party
- Sponsor
- Investigators
- Sophie Böttcher, MD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255990
- Sponsor's protocol ID
- 2022-00828
- Status last verified
- Sep 2025
- First submitted
- 31 Jan 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Study of a Novel Dermal Substitute, NovoSorb® BTM, Used in the Treatment of Full-thickness Skin Defects
- ClinicalTrials.gov ID
- NCT06255990
- Acronym / sponsor ID
- 2022-00828
- Conditions
- Skin Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- University of Zurich, Kantonsspital Aarau, Kantonsspital Winterthur KSW
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NovoSorb® BTM and STSG | – | Other: Standard of careFull thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a split-thickness skin graft (STSG) according to clinical routine |
| STSG alone | – | Other: Standard of careFull thickness skin defect qualifying for coverage with split-thickness skin graft (STSG) alone according to clinical routine |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age: 1 to 75 years
- Full-thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a STSG:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careStandard of care | Other | NovoSorb® BTM and STSG, STSG alone |
Primary outcome
Skin elasticity after 1year post-transplantation
Time frame: 1 year post-transplantation
Comparison of skin elasticity of treated skin versus adjacent normal skin
5 secondary outcomes
Histological staining
Time frame: within 1 year after skin transplantation
Skin color assessment
Time frame: within 1 year after skin transplantation
Photographical assessment
Time frame: within 1 year after skin transplantation
Change of quality of life within one year after skin transplantation
Time frame: within 1 year after skin transplantation
Immunohistochemical analyses
Time frame: 14-21 days after BTM transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Böttcher, MD principal investigator
University Children's Hospital, Zurich
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Transplantation, run by University Children's Hospital, Zurich at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Böttcher, MD (+41442497228, sophie.boettcher@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin elasticity after 1year post-transplantation (time frame: 1 year post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.