Burn InjuryPhase 1NCT02145130
Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects
A Phase 1 study testing denovoDerm and denovoSkin in people with Burn Injury and Soft Tissue Injury, run by University of Zurich at 2 sites in Switzerland.
Trial summary
The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Burn Injury, Soft Tissue Injury, Skin Necrosis
- What is being tested?
- denovoDerm and denovoSkin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSwitzerland
- Study dates
- May 2014to Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:
- Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans
- Reconstructive cases (elective surgery): scar formation after burn injuries, congenital giant nevus, skin tumours
- Informed consent by patients/parents or other legal representatives
Who cannot join
- Infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs
- Patients tested positive for HBV, HCV, syphilis or HIV
- Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
- Coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN and / or at the Investigator's discretion
- Previous enrolment of the patient into the current study
- Participation of the patient in another study within 30 days preceding and during the present study
Show all 13Show fewer
- Patients or parents/other legal representatives expected not to comply with the study protocol
- Suspicion of child abuse
- Pregnant or breast feeding females
- Contamination derived from biopsy which could interfere with patients health
- Due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently
- Skin substitute has not been released due to production specific deviations
- Patients allergic to amphotericin B and gentamicin
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Children's Hospital Zurich: denovoDerm
Zurich, Canton of Zurich, 8032
University Children's Hospital Zurich: denovoSkin
Zurich, Canton of Zurich, 8032
About this study
Official title: A Phase I, Two Armed, Open, Prospective and Multicentre Study to Evaluate the Safety of Autologous Tissue-engineered Dermal Substitutes and Dermo-epidermal Skin Substitutes for the Treatment of Large Deep Partial and Full Thickness Skin Defects in Children and Adults
The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.
- Conditions
- Burn Injury, Soft Tissue Injury, Skin Necrosis, Scars, Congenital Giant Nevus, Skin Tumors
- Being tested
- denovoDerm, denovoSkin
- Keywords
- Skin, Tissue-engineering, Autologous, Dermis, Epidermis
- Medical subject headings
- Burns, Soft Tissue Injuries, Necrosis, Cicatrix, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denovoDermBiological
Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin
denovoSkinBiological
Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed
| Study group | Role | What they receive |
|---|---|---|
| denovoDerm | Experimental | Autologous tissue-engineered dermal substitute Receives: Biological: denovoDerm |
| denovoSkin | Experimental | Autologous tissue-engineered dermo-epidermal skin substitute Receives: Biological: denovoSkin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Assessment/reporting of local infection rate and graft take
Measured: denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation
Secondary outcomes (1)
Adverse events
Assessment/reporting of number of adverse events
Measured: until 90 days post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Sophie Böttcher, PD Dr. med., Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145130
- Sponsor's protocol ID
- EuroSkinGraft / ESG-01-2011
- Status last verified
- Sep 2021
- First submitted
- 20 May 2014
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schiestl C, Neuhaus K, Meuli M, Farkas M, Hartmann-Fritsch F, Elrod J, Bressan J, Reichmann E, Bottcher-Haberzeth S. Long-Term Outcomes of a Cultured Autologous Dermo-Epidermal Skin Substitute in Children: 5-Year Results of a Phase I Clinical Trial. J Burn Care Res. 2025 Mar 4;46(2):326-334. doi: 10.1093/jbcr/irae150.
PubMed 39115183
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Two Armed, Open, Prospective and Multicentre Study to Evaluate the Safety of Autologous Tissue-engineered Dermal Substitutes and Dermo-epidermal Skin Substitutes for the Treatment of Large Deep Partial and Full Thickness Skin Defects in Children and Adults
- ClinicalTrials.gov ID
- NCT02145130
- Acronym / sponsor ID
- EuroSkinGraft / ESG-01-2011
- Conditions
- Burn Injury, Soft Tissue Injury, Skin Necrosis, Scars, Congenital Giant Nevus, Skin Tumors
- Keywords
- Skin, Tissue-engineering, Autologous, Dermis, Epidermis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- May 2014
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 22 May 2014 (estimated)
- 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 purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| denovoDerm | Experimental | Biological: denovoDermAutologous tissue-engineered dermal substitute |
| denovoSkin | Experimental | Biological: denovoSkinAutologous tissue-engineered dermo-epidermal skin substitute |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:
- Informed consent by patients/parents or other legal representatives
Key exclusion criteria (13 listed)
- Infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs
- Patients tested positive for HBV, HCV, syphilis or HIV
- Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
- Coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN and / or at the Investigator's discretion
- Previous enrolment of the patient into the current study
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 |
|---|---|---|
| denovoDermTransplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin | Biological | denovoDerm |
| denovoSkinTransplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed | Biological | denovoSkin |
Primary outcome
Safety
Time frame: denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation
Assessment/reporting of local infection rate and graft take
1 secondary outcome
Adverse events
Time frame: until 90 days post transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Derived from this study: PubMed 39115183Schiestl C, Neuhaus K, Meuli M, Farkas M, Hartmann-Fritsch F, Elrod J, Bressan J, Reichmann E, Bottcher-Haberzeth S. Long-Term Outcomes of a Cultured Autologous Dermo-Epidermal Skin Substitute in Children: 5-Year Results of a Phase I Clinical Trial. J Burn Care Res. 2025 Mar 4;46(2):326-334. doi: 10.1093/jbcr/irae150.
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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. This study is not recruiting at the moment.
Sophie Böttcher, PD Dr. med. principal investigator
University Children's Hospital, Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing denovoDerm and denovoSkin in people with Burn Injury and Soft Tissue Injury, run by University of Zurich at 2 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02145130, which also lists 1 linked publication.
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 8 Sep 2021.