Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children

Skin Wound Clinical Trial

Official title:

A Phase II, 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 Full-Thickness Defects in Adults and Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03394612
• Other study ID #: TBRU-dS-RAC-PII
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 14, 2018
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: CUTISS AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Wound

Intervention

Biological:
• 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

Locations

Country	Name	City	State
Italy	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	Città della Salute	Torino
Italy	U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona	Verona
Netherlands	Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center	Amsterdam
Netherlands	Rode Kruis Ziekenhuis	Beverwijk
Switzerland	University Children's Hospital Zurich	Zurich
Switzerland	University Hospital Zurich	Zurich

Sponsors (6)

Lead Sponsor	Collaborator
CUTISS AG	Julius Clinical, Sintesi Research Srl, University Hospital, Zürich, University of Zurich, Wyss Zurich

Countries where clinical trial is conducted

Italy,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality	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).	3 months post grafting
Secondary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality	Evaluation of scar quality at experimental area and control area, using Cutometer for elasticity measurement	3 months and 1 year +/- 30 days post grafting
Secondary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality	Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Observer Total Score	3 months and 1 year +/- 30 days post grafting
Secondary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality	Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Patient Items and Total Score	3 months and 1 year +/- 30 days post grafting
Secondary	A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality	Evaluation of scar quality at experimental area and control area, using Colormeter for skin colour measurement,.	3 months and 1 year +/- 30 days post grafting
Secondary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation	Evaluation of efficacy at experimental area and control area, calculating the epithelialized area as percentage of the total grafted area.	28 +/- 3 days post grafting
Secondary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take.	Evaluation of efficacy at experimental area and control area, assessed by the analysis of the graft take	4-11 days post grafting
Secondary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.	Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Pediatric quality of life inventory")	1 +/- 30 days year post grafting
Secondary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.	Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Patient Observer Scar Assessment Scale")	1 +/- 30 days year post grafting
Secondary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.	Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("EuroQuol 5 dimensions questionnaire")	1 +/- 30 days year post grafting
Secondary	Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.	Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Burn Specific Health Scale Brief")	1 +/- 30 days year post grafting
Secondary	Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.	Evaluation of safety at experimental area and control area based on the infection rate, assessed by using wound swabs and clinical evaluation.	4-11 days and 19-23 days post grafting
Secondary	Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events.	Evaluation of safety at experimental area and control area, assessed by the type and number of adverse events.	through study completion, an average of 3 years