EHSG-KF: Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
STSG: Transplantation of autologous split-thickness skin graft to the control area
Study 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.
Eligibility
Sex
ALL
Min age
0 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
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
* 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
* 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
Primary outcome measure(s)
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface — 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
Trial sites (4)
Facility
City
Region
Status
Dipartimento di Chirurgia Pediatrica Ospedale dei bambini Vittorio Buzzi
Milan
Italy
Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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