Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children
- Conditions
- Skin Wound
- Interventions
- Biological: EHSG-KFBiological: STSG
- Registration Number
- NCT03394612
- Lead Sponsor
- CUTISS AG
- Brief Summary
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.
- Detailed Description
This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. scar quality, in comparison to meshed STSG.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EHSG-KF and STSG Transplantation EHSG-KF Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area EHSG-KF and STSG Transplantation STSG Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area Option 1 EHSG-KF Location A is the experimental area and Location B is the control area. Option 1 STSG Location A is the experimental area and Location B is the control area. Option 2 EHSG-KF Location A is the control area and Location B is the experimental area. Option 2 STSG Location A is the control area and Location B is the experimental area.
- Primary Outcome Measures
Name Time Method Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality 3 months post grafting Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality, using the POSAS ("Patient and Observer Scar Assessment Scale"). The reported Observer Total Score can range from 1 (best) to 10 (worst).
- Secondary Outcome Measures
Name Time Method Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take. 4-11 days post grafting Evaluation of efficacy at experimental area and control area, assessed by the analysis of the graft take
Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate. 4-11 days and 19-23 days post grafting Evaluation of safety at experimental area and control area based on the infection rate, assessed by using wound swabs and clinical evaluation.
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. 1 +/- 30 days year post grafting Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Burn Specific Health Scale Brief")
A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality 3 months and 1 year +/- 30 days post grafting Evaluation of scar quality at experimental area and control area, using Colormeter for skin colour measurement,.
Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events. through study completion, an average of 3 years Evaluation of safety at experimental area and control area, assessed by the type and number of adverse events.
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality 3 months and 1 year +/- 30 days post grafting Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Patient Items and Total Score
Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation 28 +/- 3 days post grafting Evaluation of efficacy at experimental area and control area, calculating the epithelialized area as percentage of the total grafted area.
Trial Locations
- Locations (7)
Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
🇮🇹Napoli, Italy
Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
🇮🇹Napoli, Italy
U.O.C. Grandi Ustionati Azienda Ospedale Università Padova
🇮🇹Padova, Italy
Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center
🇳🇱Amsterdam, Netherlands
Rode Kruis Ziekenhuis
🇳🇱Beverwijk, Netherlands
University Children's Hospital Zurich
🇨🇭Zurich, Switzerland
University Hospital Zurich
🇨🇭Zurich, Switzerland