Skin WoundPhase 2NCT03394612
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children
A Phase 2 study testing EHSG-KF and STSG in people with Skin Wound, run by CUTISS AG at 7 sites in 3 countries.
Trial summary
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Skin Wound
- What is being tested?
- EHSG-KF and STSG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 14 Feb 2018to 21 Aug 2026
- Phase
- Phase 2
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: ≥1 years of age
- Large full-thickness defects that require coverage after excision of: Scars, Benign skin tumors (e.g. neurofibroma), Melanocytic nevus (e.g. giant nevus), Gender reassignment surgery, Soft tissue defect after trauma, Soft tissue defect after infection and debridement (e.g necrotizingn fascitis, hidadentitis suppurativa, purpura fulminans), Flap donorsite (e.g. radial forearm flap)
- Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, >16 years: minimum 45cm2
- 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
- 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
- Previous enrolment of the patient into the current phase II study
Show all 11Show fewer
- Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study
- Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
- Pregnant or breast feeding females
- Intention to become pregnant during the clinical course of the study (12 months)
- Enrolment of the Investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Italy3 sites
Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Naples
Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
Naples
U.O.C. Grandi Ustionati Azienda Ospedale Università Padova
Padova
Netherlands2 sites
Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center
Amsterdam, 1081
Rode Kruis Ziekenhuis
Beverwijk, 1940
Switzerland2 sites
University Children's Hospital Zurich
Zurich, 8032
University Hospital Zurich
Zurich, 8091
About this study
Official title: A Phase II, 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 Full-Thickness Defects in Adults and Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.
Read the detailed description
This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. scar quality, in comparison to meshed STSG.
- Conditions
- Skin Wound
- Being tested
- EHSG-KF, STSG
- Keywords
- Scar, Skin, Wound Healing, Tissue Engineering, Dermis, Epidermis
- Medical subject headings
- 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 STSG based on the assessment of scar quality
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality, using the POSAS ("Patient and Observer Scar Assessment Scale"). The reported Observer Total Score can range from 1 (best) to 10 (worst).
Measured: 3 months post grafting
Secondary outcomes (12)
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using Cutometer for elasticity measurement
Measured: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Observer Total Score
Measured: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Patient Items and Total Score
Measured: 3 months and 1 year +/- 30 days post grafting
A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using Colormeter for skin colour measurement,.
Measured: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation
Evaluation of efficacy at experimental area and control area, calculating the epithelialized area as percentage of the total grafted area.
Measured: 28 +/- 3 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take.
Evaluation of efficacy at experimental area and control area, assessed by the analysis of the graft take
Measured: 4-11 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Pediatric quality of life inventory")
Measured: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Patient Observer Scar Assessment Scale")
Measured: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("EuroQuol 5 dimensions questionnaire")
Measured: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Burn Specific Health Scale Brief")
Measured: 1 +/- 30 days year post grafting
Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.
Evaluation of safety at experimental area and control area based on the infection rate, assessed by using wound swabs and clinical evaluation.
Measured: 4-11 days and 19-23 days post grafting
Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events.
Evaluation of safety at experimental area and control area, assessed by the type and number of adverse events.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start14 Feb 2018
- Primary completion1 Dec 2023
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin WoundStudies 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
- 21 participants (actual)
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 Sc, Prof., Study chair, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394612
- Sponsor's protocol ID
- TBRU-dS-RAC-PII
- Status last verified
- Aug 2026
- First submitted
- 7 Dec 2017
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kemme FM, Pijpe A, Stoop MM, van Zuijlen PPM, Meuli M, Schiestl C, Hartmann-Fritsch F, Kim BS, Neuhaus K, Plock JA, Rittirsch D, Mujynya K, Reichmann E, Bottcher-Haberzeth S, Farkas M, Bressan J, Zamparelli M, Mataro I, Petroccione C, Pontini A, Azzena B, Marino D, Middelkoop E. Safety and efficacy of bio-engineered, autologous dermo-epidermal skin grafts in reconstructive surgery: 1-year results of a prospective, randomized, intra-patient controlled, multicenter phase II clinical trial. J Tissue Eng. 2026 Mar 23;17:20417314261429663. doi: 10.1177/20417314261429663. eCollection 2026 Jan-Dec.
PubMed 41890789Schiestl 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, 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 Full-Thickness Defects in Adults and Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
- ClinicalTrials.gov ID
- NCT03394612
- Acronym / sponsor ID
- TBRU-dS-RAC-PII
- Conditions
- Skin Wound
- Keywords
- Scar, Skin, Wound Healing, Tissue Engineering, Dermis, Epidermis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CUTISS AGIndustry (pharma, biotech, devices)
- Collaborators
- Wyss Zurich, Julius Clinical, Sintesi Research Srl, University Hospital, Zürich, University of Zurich
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 9 Jan 2018 (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 II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.
Detailed description
This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. 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
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥1 years of age
- Large full-thickness defects that require coverage after excision of: Scars, Benign skin tumors (e.g. neurofibroma), Melanocytic nevus (e.g. giant nevus), Gender reassignment surgery, Soft tissue defect after trauma, Soft tissue defect after infection and debridement (e.g necrotizingn fascitis, hidadentitis suppurativa, purpura fulminans), Flap donorsite (e.g. radial forearm flap)
- Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, >16 years: minimum 45cm2
- Signed Informed consent
Key exclusion criteria (11 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
- 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
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 STSG based on the assessment of scar quality
Time frame: 3 months post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality, using the POSAS ("Patient and Observer Scar Assessment Scale"). The reported Observer Total Score can range from 1 (best) to 10 (worst).
12 secondary outcomes
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Time frame: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Time frame: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Time frame: 3 months and 1 year +/- 30 days post grafting
A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Time frame: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation
Time frame: 28 +/- 3 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take.
Time frame: 4-11 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Time frame: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Time frame: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Time frame: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Time frame: 1 +/- 30 days year post grafting
Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.
Time frame: 4-11 days and 19-23 days post grafting
Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events.
Time frame: through study completion, an average of 3 years
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 27 Aug 2026.
- Derived from this study: PubMed 41890789Kemme FM, Pijpe A, Stoop MM, van Zuijlen PPM, Meuli M, Schiestl C, Hartmann-Fritsch F, Kim BS, Neuhaus K, Plock JA, Rittirsch D, Mujynya K, Reichmann E, Bottcher-Haberzeth S, Farkas M, Bressan J, Zamparelli M, Mataro I, Petroccione C, Pontini A, Azzena B, Marino D, Middelkoop E. Safety and efficacy of bio-engineered, autologous dermo-epidermal skin grafts in reconstructive surgery: 1-year results of a prospective, randomized, intra-patient controlled, multicenter phase II clinical trial. J Tissue Eng. 2026 Mar 23;17:20417314261429663. doi: 10.1177/20417314261429663. eCollection 2026 Jan-Dec.
- 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 Sc, Prof. study chair
University Children's Hospital, Zurich
7 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 Skin Wound, run by CUTISS AG at 7 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 11 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 27 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 7 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?
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?
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality (time frame: 3 months 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 NCT03394612, which also lists 2 linked publications.
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 27 Aug 2026.