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

• Sponsor: CUTISS AG (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03394612
• Collaborator: Wyss Zurich (Other), Julius Clinical, The Netherlands (Other), Sintesi Research Srl (Industry), University Hospital, Zürich (Other), University of Zurich (Other)
• Enrollment: 20
• Locations: 9
• Arm: 1
• Anticipated Duration (Months): 93.5
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Wound	Biological: EHSG-KF; Biological: STSG	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Feb 14, 2018
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EHSG-KF and STSG Transplantation Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area	Biological: EHSG-KF; Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area; Other Names: denovoSkin ; Biological: STSG; Transplantation of autologous split-thickness skin graft to the control area; Other Names: Split-thickness skin graft

Outcome Measures

Primary Outcome Measures

1. 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

1. 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 Cutometer for elasticity measurement

2. 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") Observer Total Score

3. 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

4. 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,.

5. 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.

6. 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

7. 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 ("Pediatric quality of life inventory")

8. 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 ("Patient Observer Scar Assessment Scale")

9. 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 ("EuroQuol 5 dimensions questionnaire")

10. 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")

11. 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.

12. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli	Napoli		Italy
2	Unità di Chirurgia Plastica e Ustioni Ospedale Santobono	Napoli		Italy
3	U.O.C. Grandi Ustionati Azienda Ospedale Università Padova	Padova		Italy
4	Città della Salute	Torino		Italy	10126
5	U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona	Verona		Italy
6	Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center	Amsterdam		Netherlands	1081
7	Rode Kruis Ziekenhuis	Beverwijk		Netherlands	1940
8	University Children's Hospital Zurich	Zurich		Switzerland	8032
9	University Hospital Zurich	Zurich		Switzerland	8091

Sponsors and Collaborators

• CUTISS AG
• Wyss Zurich
• Julius Clinical, The Netherlands
• Sintesi Research Srl
• University Hospital, Zürich
• University of Zurich

Investigators

• Study Chair: Clemens Sc, Prof., University Children's Hospital, Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CUTISS AG
• ClinicalTrials.gov Identifier: NCT03394612
• Other Study ID Numbers: TBRU-dS-RAC-PII
• First Posted: Jan 9, 2018
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CUTISS AG: Scar; Skin; Wound Healing; Tissue Engineering; Dermis; Epidermis

Study Results

No Results Posted as of Jun 7, 2022