AzTrials
AzTrials

BurnsPhase 2NCT03227146

Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

A Phase 2 study testing EHSG-KF and STSG in people with Burns, run by CUTISS AG at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns. Read more about this study

Who is it for?
Ages 12 years and older
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
14 participants
Where
6 sitesin 3 countries
Study dates
25 Oct 2017to 28 Aug 2025
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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
  • 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 12Show 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)
  • 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

6 sites in 3 countries.

6 sites in 3 countries

Italy2 sites

  • Chirurgia Plastica e Centro Grandi Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

    Naples

  • Unità di Chirurgia Plastica e Ustioni Ospedale Santobono

    Naples

Other trials in Italy

Netherlands2 sites

  • Rode Kruis Ziekenhuis

    Beverwijk, 1940

  • Maasstad Ziekenhuis

    Rotterdam, 3079

Other trials in Netherlands

Switzerland2 sites

  • University Children's Hospital Zurich

    Zurich, Canton of Zurich, 8032

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

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 Adults and Adolescents 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 adults and adolescents with partial deep dermal and full thickness burns.

Read the detailed description

This multicentre phase IIb clinical trial will target adults and adolescents 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 groups in NCT03227146
Study groupRoleWhat they receive
Option 1OtherLocation A is the experimental area and Location B is the control area.
Receives: Biological: EHSG-KF; Biological: STSG
Option 2OtherLocation 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted24 Jul 2017
  2. Study start25 Oct 2017
  3. Primary completion30 Nov 2022
  4. Study completion28 Aug 2025

Resources

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03227146
Sponsor's protocol ID
TBRU-dS-BA-PIIb
Other IDs
NL62252.000.17; CS2/1421
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

  • Meuli M, Schiestl C, Hartmann-Fritsch F, Middelkoop E, Kim BS, Neuhaus K, Plock JA, Rittirsch D, van der Vlies CH, Azzena B, Marino D, Mujynya K, Farkas M, Bressan J, Reichmann E, Bottcher-Haberzeth S. Safety and efficacy of bio-engineered, autologous dermo-epidermal skin grafts in adolescent and adult burn patients: 1-year results of a prospective, randomized, controlled, multicenter phase IIB clinical trial. EClinicalMedicine. 2025 Nov 28;90:103665. doi: 10.1016/j.eclinm.2025.103665. eCollection 2025 Dec.

    PubMed 41399471

  • 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

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 6 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 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: finished, 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 6 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 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 NCT03227146, 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 6 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in