Can Lab-Grown skin heal large wounds with better scars?
NCT ID NCT03394612
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests an engineered skin substitute called denovoSkin, made from a patient's own skin cells, against the standard split-thickness skin graft for covering large full-thickness wounds. Adults and children with such wounds from burns, trauma, or surgery will have both treatments applied to different areas of the same wound. Researchers will compare scar quality and safety to see if denovoSkin can offer a better alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- An engineered skin substitute made from the patient's own skin cells, called denovoSkin (EHSG-KF), compared with a standard split-thickness skin graft.
- What this could lead to
- If it works, denovoSkin could offer a way to cover large wounds with less donor skin and better scarring, reducing pain and improving recovery for patients.
- What could go wrong
- This is a small phase II trial, so results may not hold up in larger studies. The engineered skin might not take as well as standard grafts, and there are risks of infection or poor healing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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21 people
The number who actually took part.
- Started
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Feb 2018
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Naples, Italy
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Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center
Amsterdam, 1081, Netherlands
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Rode Kruis Ziekenhuis
Beverwijk, 1940, Netherlands
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U.O.C. Grandi Ustionati Azienda Ospedale Università Padova
Padova, Italy
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Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
Naples, Italy
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University Children's Hospital Zurich
Zurich, 8032, Switzerland
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University Hospital Zurich
Zurich, 8091, Switzerland
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