Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03229564
Other study ID # TBRU-dS-BC-PIIb
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 25, 2017
Est. completion date December 2025

Study information

Verified date February 2023
Source CUTISS AG
Contact Clemens Schiestl, Prof.
Phone +41 44 266 73 93
Email clemens.schiestl@kispi.uzh.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.


Description:

This multicentre phase IIb clinical trial will target patients from 1-17 years with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 2025
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Years
Eligibility Inclusion Criteria: - Age: <12 years of age - Deep partial thickness and/or full-thickness burns requiring surgical wound coverage - 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. - 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 - Patients with a known history of malignancy - 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 or parents/legal guardian expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) - Pregnant or breast feeding females - Suspicion of child abuse - Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands) - Enrolment of the Investigator, his/her family members, employees and other dependent persons

Study Design


Related Conditions & MeSH terms


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 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 Rode Kruis Ziekenhuis Beverwijk
Switzerland University Children's 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 meshed STSG based on ratio of covered surface 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 Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection Evaluation of clinical signs of infection at experimental area and control area 4-11 days post grafting and 21 +/-2 days post grafting
Secondary Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection Evaluation of microbiologic signs of infection at experimental area and control area 4-11 days post grafting and 21 +/-2 days post grafting
Secondary Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R) Assessment of elasticity of experimental area and control area using Cutometer(R) 1 year +/-30 days post grafting
Secondary Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of general scar quality using POSAS assessment tool Assessment of general scar quality of experimental area and control area using POSAS assessment tool 1 year +/-30 days post grafting
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Completed NCT05276869 - Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Not yet recruiting NCT06076031 - Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing N/A
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Recruiting NCT04090424 - Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03159182 - Study of Silicone Material Inserts To Treat Burn Scars N/A
Recruiting NCT02904941 - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns N/A
Completed NCT02681757 - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Completed NCT01214811 - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing Phase 3
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Terminated NCT00824681 - Effect of Music Therapy on Families of Burn Patients Phase 1
Terminated NCT00634166 - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group Phase 4
Terminated NCT00464386 - Continuous Glucose Monitoring (POC) in the ICU N/A
Withdrawn NCT00216983 - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding N/A