BurnsPhase 2NCT03229564
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
A Phase 2 study testing EHSG-KF and STSG in people with Burns, run by CUTISS AG at 4 sites in 3 countries.
Trial summary
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns. Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Burns
- What is being tested?
- EHSG-KF and STSG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 25 Oct 2017to Jun 2028
- Phase
- Phase 2
- 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 0 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: <12 years of age
- Deep partial thickness and/or full-thickness burns requiring surgical wound coverage
- Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in The Netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. >20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion.
- Signed Informed consent
Who cannot join
- 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. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing)
- Severe drug and alcohol abuse
- Patients with a known history of malignancy
- Pre-existing coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN prior to the current hospital admission and / or at the Investigator's discretion
- Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen
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- Previous enrolment of the patient into the current phase II study
- Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study
- Patients or parents/legal guardian expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
- Pregnant or breast feeding females
- Suspicion of child abuse
- Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands)
- Enrolment of the Investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Italy2 sites
Dipartimento di Chirurgia Pediatrica Ospedale dei bambini Vittorio Buzzi
Milan
Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
Naples
About this study
Official title: A Phase IIb, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Partial Deep Dermal and Full Thickness Burns in Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.
Read the detailed description
This multicentre phase IIb clinical trial will target patients from 1-17 years with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG.
- Conditions
- Burns
- Being tested
- EHSG-KF, STSG
- Keywords
- Burns, Scar, Skin, Wound healing, Tissue Engineering, Dermis, Epidermis, Thermal Injuries
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHSG-KFBiological
Also called denovoSkin
Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
STSGBiological
Also called Split-thickness skin graft
Transplantation of autologous split-thickness skin graft 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: EHSG-KF; Biological: STSG |
| Option 2 | Other | Location A is the control area and Location B is the experimental area. Receives: Biological: EHSG-KF; Biological: STSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area
Measured: 4 weeks post grafting
Secondary outcomes (4)
Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection
Evaluation of clinical signs of infection at experimental area and control area
Measured: 4-11 days post grafting and 21 +/-2 days post grafting
Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection
Evaluation of microbiologic signs of infection at experimental area and control area
Measured: 4-11 days post grafting and 21 +/-2 days post grafting
Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R)
Assessment of elasticity of experimental area and control area using Cutometer(R)
Measured: 1 year +/-30 days post grafting
Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of general scar quality using POSAS assessment tool
Assessment of general scar quality of experimental area and control area using POSAS assessment tool
Measured: 1 year +/-30 days post grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start25 Oct 2017
- Primary completion26 Nov 2025
- Study completionJun 2028 (estimated)
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CUTISS AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wyss Zurich, Julius Clinical, Sintesi Research Srl, University Hospital, Zürich, University of Zurich
- Responsible party
- Sponsor
- Investigators
- Clemens Schiestl, Prof., Study chair, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229564
- Sponsor's protocol ID
- TBRU-dS-BC-PIIb
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2017
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Partial Deep Dermal and Full Thickness Burns in Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
- ClinicalTrials.gov ID
- NCT03229564
- Acronym / sponsor ID
- TBRU-dS-BC-PIIb
- Conditions
- Burns
- Keywords
- Burns, Scar, Skin, Wound healing, Tissue Engineering, Dermis, Epidermis, Thermal Injuries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- CUTISS AGIndustry (pharma, biotech, devices)
- Collaborators
- Wyss Zurich, Julius Clinical, Sintesi Research Srl, University Hospital, Zürich, University of Zurich
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Jul 2017 (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 phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.
Detailed description
This multicentre phase IIb clinical trial will target patients from 1-17 years with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Option 1 | Other | Biological: EHSG-KF, Biological: STSGLocation A is the experimental area and Location B is the control area. |
| Option 2 | Other | Biological: EHSG-KF, Biological: STSGLocation A is the control area and Location B is the experimental area. |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: <12 years of age
- Deep partial thickness and/or full-thickness burns requiring surgical wound coverage
- Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in The Netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. >20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion.
- Signed Informed consent
Key exclusion criteria (13 listed)
- 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. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing)
- Severe drug and alcohol abuse
- Patients with a known history of malignancy
- Pre-existing coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN prior to the current hospital admission and / or at the Investigator's discretion
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 |
|---|---|---|
| EHSG-KFAlso: denovoSkinTransplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area | Biological | Option 1, Option 2 |
| STSGAlso: Split-thickness skin graftTransplantation of autologous split-thickness skin graft to the control area | Biological | Option 1, Option 2 |
Primary outcome
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface
Time frame: 4 weeks post grafting
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area
4 secondary outcomes
Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection
Time frame: 4-11 days post grafting and 21 +/-2 days post grafting
Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection
Time frame: 4-11 days post grafting and 21 +/-2 days post grafting
Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R)
Time frame: 1 year +/-30 days post grafting
Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of general scar quality using POSAS assessment tool
Time frame: 1 year +/-30 days 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 6 Aug 2026.
- 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.
- 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. This study is not recruiting at the moment.
Clemens Schiestl, Prof. study chair
University Children's Hospital, Zurich
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EHSG-KF and STSG in people with Burns, run by CUTISS AG at 4 sites in 3 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 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: under way, not looking for participants, as of the sponsor's last update on 6 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 4 sites in Italy, Netherlands, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface (time frame: 4 weeks post grafting). 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 NCT03229564, 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 6 Aug 2026.