BurnsPhase 3NCT06745557
Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
A Phase 3 study testing denovoSkin(TM) and STSG in people with Burns, run by CUTISS AG at 19 sites in 9 countries.
Trial summary
This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Burns
- What is being tested?
- denovoSkin(TM) and STSG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 19 sitesin 9 countries
- Study dates
- 13 Dec 2024to 30 Jun 2029
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (TBSA) for which excision and standard of care (SOC) (STSG) are clinically indicated
- Patients of either sex aged ≥12 years
- Signed informed consent from the patient and/or legally authorised representative
Who cannot join
- Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck)
- Patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoSkin™, for whom the application of denovoSkin™ would delay the standard of care therapies
- Patients with serologic evidence of active hepatitis B virus (HBV) infection (i.e., positive for Hepatitis B surface antigen [HbsAg] or immunoglobulin M total hepatitis B core antibody [anti-HBc]), active hepatitis C infection (hepatitis C virus [HCV] antibody positive), positive human immunodeficiency virus (HIV) serology, or positive Treponema pallidum serology assessed as per local standard of care; cured hepatitis C (defined as documented treatment and negative viral load) is not an exclusion
- Patients with known underlying or concomitant medical conditions that, in the opinion of the Investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (HbA1c) ≥53 mmol/mol and/or systemic skin and connective tissue diseases
- Patients with pre-existing coagulation disorders as defined by international normalised ratio (INR) outside its normal value, a prothrombin time (PT) greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission
- Patients with a history of clinically significant hypersensitivity to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen and it's derivatives (e.g. gelatine)
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- Previous treatment with denovoSkin™
- Participation in any clinical interventional study within 60 days prior to the first IMP administration in case of monoclonal antibodies and <30 days for all other IMPs
- Patients unwilling or unable to comply with procedures required in this clinical study protocol
- Pregnant or lactating women
- Women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate <1% per year) throughout the study and/or unwilling to be tested for pregnancy. A negative serum beta-human chorionic gonadotropin (β-hCG) test is required on the day of grafting
- Patient is the Investigator, one of his/her family members, employees, and other dependent persons
Trial locations and contacts
19 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 9 countries
Germany4 sites, 4 recruiting
- Recruiting
BG Klinikum Unfallkrankenhaus Berlin
Berlin, 12683
Hartmann, Dr., +49 30 56 81 35 01, bernd.hartmann@ukb.de
- Recruiting
BG Klinikum Bergmannstrost Halle
Halle, 06112
Siemers, Prof., +49 (0) 345 132 - 6333, siemers@bergmannstrost.de
- Not yet recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Dastagir, Dr., +49 (0) 176 61214342, Dastagir.Khaled@mh-hannover.de
- Recruiting
BG-Unfallklinik Murnau
Murnau am Staffelsee, 82418
Wallner, Dr., +49 8841 48 46 84, Britta.Wallner@bgu-murnau.de
France3 sites, 3 recruiting
- Recruiting
Hopital Edouard Herriot Centre des Brûlés de Lyon
Lyon, 69003
Serbu, Dr., +33 4 72 11 75 83, maria.serbu@chu-lyon.fr
- Recruiting
Pharmacie Hôpital Conception
Marseille, 13005
Hautier, Dr., +33 4 91 38 39 38, Aurelie.HAUTIER@ap-hm.fr
- Recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
Herlin, Prof., +33 4 67 33 05 89, c-herlin@chu-montpellier.fr
Italy3 sites, 3 recruiting
- Recruiting
Santobono-Pausilipon
Naples, 80129
Zamparelli, Prof., +39 347 0897148, m.zamparelli@santobonopausilipon.it
- Recruiting
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Naples, 80131
Mataro, Dr., +39 333 3486 437, ilaria.mataro@aocardarelli.it
- Not yet recruiting
AOU Padova
Padova, 35128
Bassetto, Prof., +39 347 2414280, franco.bassetto@unipd.it
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Serracanta, Dr., +34 937 275 520, Jordi.serracanta@vallhebron.cat
- Recruiting
Hospital Universitario La Paz Edificio Traumatología
Madrid, 28046
MARTINEZ MENDEZ, Prof., +34 609 579 614, Josermartinez77@gmail.com
- Recruiting
Hospital Universitatrio y Politécnico La Fe
Valencia, 46026
Perez Del Caz, Prof., +34 607 08 28 77, draperezdelcaz@gmail.com
Netherlands2 sites, 2 recruiting
- Recruiting
Rode Kruis Ziekenhuis
Beverwijk, 1942
Prof. E. Middelkoop, +31 251 265 555, emiddelkoop@burns.nl
- Recruiting
Maasstad Hospital Dep. Burn Wound Centre
Rotterdam, 3079 DZ
Van Der Vlies, Dr., +31 (0)10 2912789, VliesC@maasstadziekenhuis.nl
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège Département de pharmacie hospitalière - Secteur Essais cliniques
Liège, B-4000
Martin, Dr., +32 4 323 48 04, Francois.Martin@chuliege.be
Poland1 site, 1 recruiting
- Recruiting
Samodzielny Zakład Opieki Zdrowotnej z siedzibą w Łęcznej
Łęczna, 21-010
KORZENIOWSKI, Dr., +48 602 797 279, t.korzeniowski@gmail.com
Portugal1 site, 1 recruiting
- Recruiting
Unidade de Queimados do CHUC
Coimbra, 3000-075
Cabral, Prof., +351 919676728, jlacabral@gmail.com
Switzerland1 site, 1 recruiting
- Recruiting
Universtitätsspital Zürich
Zurich, 8091
Kim, Dr., +41 44 255 33 39, Bong-Sung.Kim@usz.ch
About this study
Official title: A Multicentre, Intra-patient Randomised Controlled Phase III Study to Confirm the Efficacy and Safety of denovoSkin™, a Bilayer Engineered Collagen-based Skin Graft Composed of Autologous Fibroblasts and Keratinocytes, for the Treatment of Patients With Deep Partial and Full-thickness Burns
This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.
- Conditions
- Burns
- Being tested
- denovoSkin(TM), STSG
- Keywords
- Burns, Skin, Scars, Wound healing, Dermis, Epidermis, Thermal burns
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denovoSkin(TM)Biological
Also called EHSG-KF
Transplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area
STSGOther
Also called split-thickness skin graft
Transplantation of autologous split-thickness skin to the control area
| Study group | Role | What they receive |
|---|---|---|
| Option 1 | Other | Location A is the experimental area and Location B is the control area Receives: Biological: denovoSkin(TM); Other: STSG |
| Option 2 | Other | Location A is the control area and Location B is the experimental area Receives: Biological: denovoSkin(TM); Other: STSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite endpoint whereby success is defined by meeting both of the following criteria: - Wound closure - Scar quality (POSAS v2.0)
A composite endpoint whereby success is defined by meeting both of the following criteria:
- Wound closure
- Scar quality (POSAS v2.0)
Measured: 6 months post grafting
Secondary outcomes (7)
Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting
Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting
Measured: 4 weeks
Assessment of scar contracture
Assessment of scar contracture
Measured: 6 months post grafting
Epithelialisation percentage at 3 months and 6 months post-grafting
Epithelialisation percentage at 3 months and 6 months post-grafting
Measured: 3 months and 6 months post-grafting
Graft take at 14 and 21 days post-grafting
Graft take at 14 and 21 days post-grafting
Measured: 14 and 21 days post-grafting
Assessment of the donor sites
Assessment of the donor sites
Measured: 4 and 10 weeks, and 3, 6, 12, and 24 months post-grafting
Assessment of the grafted burn wounds areas
Assessment of the grafted burn wounds areas
Measured: 4 and 10 weeks and 3, 6, 12, and 24 months post-grafting
Assessment of scar contracture
Assessment of scar contracture
Measured: 12 and 24 months post-grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start13 Dec 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Intra-patient randomisation
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CUTISS AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RCTs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745557
- Sponsor's protocol ID
- dS-BA-PIII
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Intra-patient Randomised Controlled Phase III Study to Confirm the Efficacy and Safety of denovoSkin™, a Bilayer Engineered Collagen-based Skin Graft Composed of Autologous Fibroblasts and Keratinocytes, for the Treatment of Patients With Deep Partial and Full-thickness Burns
- ClinicalTrials.gov ID
- NCT06745557
- Acronym / sponsor ID
- dS-BA-PIII
- Conditions
- Burns
- Keywords
- Burns, Skin, Scars, Wound healing, Dermis, Epidermis, Thermal burns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- CUTISS AGIndustry (pharma, biotech, devices)
- Collaborators
- RCTs
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 Dec 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.
This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intra-patient randomisation
| Arm | Type | Receives |
|---|---|---|
| Option 1 | Other | Biological: denovoSkin(TM), Other: STSGLocation A is the experimental area and Location B is the control area |
| Option 2 | Other | Biological: denovoSkin(TM), Other: STSGLocation A is the control area and Location B is the experimental area |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (TBSA) for which excision and standard of care (SOC) (STSG) are clinically indicated
- Patients of either sex aged ≥12 years
- Signed informed consent from the patient and/or legally authorised representative
Key exclusion criteria (12 listed)
- Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck)
- Patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoSkin™, for whom the application of denovoSkin™ would delay the standard of care therapies
- Patients with serologic evidence of active hepatitis B virus (HBV) infection (i.e., positive for Hepatitis B surface antigen [HbsAg] or immunoglobulin M total hepatitis B core antibody [anti-HBc]), active hepatitis C infection (hepatitis C virus [HCV] antibody positive), positive human immunodeficiency virus (HIV) serology, or positive Treponema pallidum serology assessed as per local standard of care; cured hepatitis C (defined as documented treatment and negative viral load) is not an exclusion
- Patients with known underlying or concomitant medical conditions that, in the opinion of the Investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (HbA1c) ≥53 mmol/mol and/or systemic skin and connective tissue diseases
- Patients with pre-existing coagulation disorders as defined by international normalised ratio (INR) outside its normal value, a prothrombin time (PT) greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission
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 |
|---|---|---|
| denovoSkin(TM)Also: EHSG-KFTransplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area | Biological | Option 1, Option 2 |
| STSGAlso: split-thickness skin graftTransplantation of autologous split-thickness skin to the control area | Other | Option 1, Option 2 |
Primary outcome
A composite endpoint whereby success is defined by meeting both of the following criteria: - Wound closure - Scar quality (POSAS v2.0)
Time frame: 6 months post grafting
A composite endpoint whereby success is defined by meeting both of the following criteria: * Wound closure * Scar quality (POSAS v2.0)
7 secondary outcomes
Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting
Time frame: 4 weeks
Assessment of scar contracture
Time frame: 6 months post grafting
Epithelialisation percentage at 3 months and 6 months post-grafting
Time frame: 3 months and 6 months post-grafting
Graft take at 14 and 21 days post-grafting
Time frame: 14 and 21 days post-grafting
Assessment of the donor sites
Time frame: 4 and 10 weeks, and 3, 6, 12, and 24 months post-grafting
Assessment of the grafted burn wounds areas
Time frame: 4 and 10 weeks and 3, 6, 12, and 24 months post-grafting
Assessment of scar contracture
Time frame: 12 and 24 months post-grafting
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 10 Aug 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.
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing denovoSkin(TM) and STSG in people with Burns, run by CUTISS AG at 19 sites in 9 countries.
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 3 inclusion and 12 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, France, Italy, Spain, Netherlands and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Daniela Marino (+41 44 244 36 60, clinicaltrials@cutiss.swiss), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite endpoint whereby success is defined by meeting both of the following criteria: - Wound closure - Scar quality (POSAS v2.0) (time frame: 6 months post grafting). 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 10 Aug 2026.