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Medical-scientific research into a new own skin graft product (EHSG-KF)
EU CTIS ID: 2024-512188-29-00
What this study is testing
To evaluate the efficacy and safety of EHSG-KF in comparison to meshed STSG in adults and adolescents with partial deep dermal and full-thickness burns. Primary Objective: To evaluate the efficacy of EHSG-KF in comparison to meshed STSG based on: Ratio of covered surface area to biopsy site/donor site surface area 4 weeks post grafting
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 from the patient or the parents/legally authorized representative.
You likely can't join if
- Patients tested positive for HBV, HCV, syphilis or HIV
- 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
- Patients with a known history of malignancy
See the full eligibility 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 from the patient or the parents/legally authorized representative.
- Patients tested positive for HBV, HCV, syphilis or HIV
- 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
- Patients with a known history of malignancy
- Intention to become pregnant during the clinical course of the study (12 months)
- Suspicion of non-accidental injury
- 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
- 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
- Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.