Can Lab-Grown skin heal large wounds with better scars?

NCT ID NCT03394612

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Feb 2018

Finished

Aug 2026

Lead sponsor

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

1 year and older

Sex

Anyone

Healthy volunteers

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

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

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

    Naples, Italy

  • Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center

    Amsterdam, 1081, Netherlands

  • Rode Kruis Ziekenhuis

    Beverwijk, 1940, Netherlands

  • U.O.C. Grandi Ustionati Azienda Ospedale Università Padova

    Padova, Italy

  • Unità di Chirurgia Plastica e Ustioni Ospedale Santobono

    Naples, Italy

  • University Children's Hospital Zurich

    Zurich, 8032, Switzerland

  • University Hospital Zurich

    Zurich, 8091, Switzerland

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