Clinical trial NCT03229564: Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
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 Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Burns
Keywords: Burns
Scar
Skin
Wound healing
Tissue Engineering
Dermis
Epidermis
Thermal Injuries
Lead sponsor: CUTISS AG
Sponsor class: INDUSTRY
Collaborators: name: Wyss Zurich
name: Julius Clinical
name: Sintesi Research Srl
name: University Hospital, Zürich
name: University of Zurich
First posted: 2017-07-25
Enrollment: 12
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This multicentre phase IIb clinical trial will target patients from 1-17 years 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.

Eligibility criteria: 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 outcomes:
measure: Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface
timeFrame: 4 weeks post grafting
Secondary outcomes:
measure: Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection
timeFrame: 4-11 days post grafting and 21 +/-2 days post grafting
measure: Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection
timeFrame: 4-11 days post grafting and 21 +/-2 days post grafting
measure: Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R)
timeFrame: 1 year +/-30 days post grafting
measure: 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
timeFrame: 1 year +/-30 days post grafting
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Dipartimento di Chirurgia Pediatrica Ospedale dei bambini Vittorio Buzzi
city: Napoli
country: Italy
facility: Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Clemens Schiestl, Prof.
role: STUDY_CHAIR
References: