A Phase IIb, 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 partial deep dermal and full thickness burns in children in comparison to autologous split-thickness skin grafts (STSG) (BC)

Conditions

Children with partial deep dermal and full thickness burns

Brief summary

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)

Detailed description

% Epithelialization at: - visit 8 (90 ± 5 days post grafting), Safety and efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: see point 3 - 6, Main secondary safety endpoint: Clinical and microbiologic signs of infection at: o visit 4 (6-10 days post grafting) o visit 5 (21 ± 2 days post grafting), 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), 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., Other secondary efficacy endpoint: Epithelialization at: o visit 6 (28 ± 3 days post grafting)

Related papers

No related papers found yet.

Interventions

DRUGEHSG-KF

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
% Epithelialization at: - visit 8 (90 ± 5 days post grafting), Safety and efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: see point 3 - 6, Main secondary safety endpoint: Clinical and microbiologic signs of infection at: o visit 4 (6-10 days post grafting) o visit 5 (21 ± 2 days post grafting), 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), 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., Other secondary efficacy endpoint: Epithelialization at: o visit 6 (28 ± 3 days post grafting)	—

Measure

Time frame

% Epithelialization at: - visit 8 (90 ± 5 days post grafting), Safety and efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: see point 3 - 6, Main secondary safety endpoint: Clinical and microbiologic signs of infection at: o visit 4 (6-10 days post grafting) o visit 5 (21 ± 2 days post grafting), 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), 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., Other secondary efficacy endpoint: Epithelialization at: o visit 6 (28 ± 3 days post grafting)

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Countries

Italy, Netherlands

Outcome results

None listed