Medical-scientific research into a new own skin graft product (EHSG-KF)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cutiss AG

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

13 May 2019 → ongoing

Decision date (initial)

2024-11-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Wyss Zurich

External identifiers

EU CT number

2024-512190-27-00

EudraCT number

2017-002462-41

ClinicalTrials.gov

NCT03394612

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To evaluate the efficacy and safety of EHSG-KF in comparison to STSG (unmeshed or meshed up to 1:3) in adults and children with large full-thickness skin defects.
Primary Objective:
To evaluate the efficacy of EHSG-KF in comparison to STSG based on the assessment of:
• Scar quality:
o POSAS questionnaire, observer total score 3 months post grafting

Secondary objectives 1

1. To evaluate the safety and efficacy of EHSG-KF in comparison to STSG (unmeshed or meshed up to 1:3) based on the assessment of: • Scar quality: o Cutometer® 3 months post grafting o POSAS questionnaire, observer items 3 months post grafting o POSAS questionnaire, patient items and total score 3 months post grafting o DSM ColorMeter® (1 year post grafting) o Optional biopsies of the study area and control area (1 year post grafting) for histological assessment. (optional) • Infection 6-10 days and 3 weeks post grafting • Graft take at 6-10 days post grafting • % Epithelialization at 4 weeks post grafting • Adverse events • QOL assessment (1 year) post grafting o EQ-5D and BSHS-B for patients ≥ 18 with reconstruction of burn scars, o EQ-5D only for patients ≥18 years without burn scars o EQ-5DY and PedsQL for patients <18 years • Ratio of covered surface area to biopsy site/donor site surface area 4 weeks post grafting

Conditions and MedDRA coding

Adults and children with full thickness skin defects

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age: ≥1 year of age
2. Large full-thickness defects that require coverage after excision of: o Scars o Benign skin tumors (e.g. neurofibroma) o Melanocytic nevus (e.g. giant nevus) o Gender reassignment surgery o Soft tissue defect after trauma o Soft tissue defect after infection and debridement (e.g. necrotizing fascitis, hidradentitis suppurativa, purpura fulminans) o Flap donor site (e.g. radial forearm flap)
3. Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): o Minimum: 1-5 years: 9 cm2 o Minimum: 6-16 years: 25 cm2 o Minimum: > 16 years: 45 cm2
4. Signed informed consent from the patient or the parents/legally authorized representative.

Exclusion criteria 12

1. Patients tested positive for HBV, HCV, syphilis or HIV
2. 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)
3. Severe drug and alcohol abuse
4. Pre-existing coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen prior to the current hospital admission and / or at the Investigator’s discretion
5. Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen
6. Previous enrolment of the patient into the current phase II study
7. Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study
8. Patients or parents/legally authorized representative expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
9. Pregnant or breast feeding females
10. Intention to become pregnant during the clinical course of the study (12 months)
11. Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands)
12. Enrolment of the Investigator, his/her family members, employees, and other dependent persons

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on assessment of general scar quality at the study areas using the POSAS questionnaire, observer total score at: visit 8 (90 days ± 5 days post grafting)

Secondary endpoints 5

1. Efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on (1): • Scar quality at the study areas in comparison to control areas: o Cutometer® pliability parameter at visit 8 (90 days ± 5 days post grafting) as key secondary efficacy endpoint o Other Cutometer® parameters (extension, elasticity, retraction, viscoelasticity) at visit 8 (90 days ± 5 days post grafting)
2. Based on (2): • Scar quality at the study areas in comparison to control areas: o POSAS questionnaire observer items (vascularity, pigmentation, thickness, relief, pliability) at visit 8 (90 days ± 5 days post grafting) o POSAS questionnaire patient items (pain, itching, colour, pliability, thickness, relief) and total score at visit 8 (90 days ± 5 days after grafting)
3. Based on (3): • Scar quality at the study areas in comparison to control areas: DSM ColorMeter® (erythema and pigmentation) at: visit 10 (1 year ± 30 days post grafting) o Optional biopsies of the study area and control area at visit 10 (1 year ± 30 days after grafting) for histological assessment. (optional) o Graft take at Visit 4 (6-10 days after grafting) o % Epithelialization at Visit 6 (28 days ± 3 days after grafting)
4. Secondary safety endpoints: • Clinical and microbiologic signs of infection at o visit 4 (6-10 days post grafting) o visit 5 (21 ± 2 days post grafting) • Adverse events o Assessment and reporting of all observed adverse events will be carried out for the full duration of the study from visit 2 on.
5. Other secondary efficacy endpoint: • QOL assessment: visit 10 (1 year ± 30 days post grafting) o EQ-5D and BSHS-B for patients ≥18 years with reconstruction of burn scars o EQ-5D only for patients ≥18 years without burn scars o EQ-5DY and PedsQL for patients <18 years

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cutiss AG

Sponsor organisation

Cutiss AG

Address

Grabenstrasse 11

City

Schlieren

Postcode

8952

Country

Switzerland

Scientific contact point

Organisation

Cutiss AG

Contact name

Fabienne Hartmann

Public contact point

Organisation

Cutiss AG

Contact name

Fabienne Hartmann

Locations

2 EU/EEA countries · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications