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

20 Jan 2020 → 13 Sep 2025

Decision date (initial)

2024-10-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Wyss Zurich

External identifiers

EU CT number

2024-512188-29-00

EudraCT number

2017-002460-41

ClinicalTrials.gov

NCT03227146

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

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

Secondary objectives 2

1. First Secondary Objective • % Epithelialization at 3 months post grafting
2. To evaluate the safety and efficacy of EHSG-KF in comparison to meshed STSG based on the assessment of: • Infection • Scar quality: o Cutometer® 3, 6, 12, 24 and 36 months post grafting o DSM ColorMeter® 3, 6, 12, 24 and 36 months post grafting o POSAS-questionnaire 3, 6, 12, 24 and 36 months post grafting • Graft take at 6-10 days post grafting • %Epithelialization (to estimate ‘time to complete epithelialization’) at 3 and 4 weeks, and 2 and 6 months post grafting • Incidence of wound closure at 4, 8, and 12 weeks post grafting • Growth (% change in surface area, cm2, between 1 and 3 years post grafting) • Assessment and reporting of all observed adverse events • QOL assessment (EQ-5D and BSHS-B for patients ≥18 years; EQ-5DY and PedsQL for patients <18 years) • Healthcare resource utilization (direct and indirect healthcare costs, this questionnaire will not be handed out to patients)

Conditions and MedDRA coding

Adults and adolescents with partial deep dermal and full thickness burns

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age: ≥12 years of age
2. Deep partial thickness and/or full-thickness burns requiring surgical wound coverage
3. 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.
4. Signed informed consent from the patient or the parents/legally authorized representative.

Exclusion criteria 14

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

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: • Ratio of covered surface area to biopsy site/donor site surface area at visit 6 (28 +/-3 days post grafting)

Secondary endpoints 6

1. % Epithelialization at: o visit 8 (90 ± 5 days post grafting)
2. Safety and efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: secondary endpoints 3-6
3. - Main secondary safety endpoint: Clinical and microbiologic signs of infection at visit 4 (6-10 days post grafting) and visit 5 (21 ± 2 days post grafting)
4. - Main secondary efficacy endpoints: Scar quality at the study areas o Assessment of elasticity of the study areas using the Cutometer® at visit 10 (1 year ± 30 days post grafting) o Assessment of general scar quality at the study areas using the POSAS, a reliable and validated scar assessment tool, at: visit 10 (1 year ± 30 days post grafting)
5. - Other secondary safety endpoint: Assessment and reporting of all observed adverse events will be carried out for the full duration of the study from visit 2 on.
6. - Other secondary efficacy endpoint: Epithelialization at: o visit 6 (28 ± 3 days post grafting)

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

1 EU/EEA country · 2 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 9 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