Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03394612
Other study ID # TBRU-dS-RAC-PII
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 14, 2018
Est. completion date December 2026

Study information

Verified date November 2023
Source CUTISS AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 2026
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility 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

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 Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli Napoli
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 Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center Amsterdam
Netherlands Rode Kruis Ziekenhuis Beverwijk
Switzerland University Children's Hospital Zurich Zurich
Switzerland University 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 STSG based on the assessment of scar quality 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). 3 months post grafting
Secondary Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality Evaluation of scar quality at experimental area and control area, using Cutometer for elasticity measurement 3 months and 1 year +/- 30 days post grafting
Secondary Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Observer Total Score 3 months and 1 year +/- 30 days post grafting
Secondary Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Patient Items and Total Score 3 months and 1 year +/- 30 days post grafting
Secondary A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality Evaluation of scar quality at experimental area and control area, using Colormeter for skin colour measurement,. 3 months and 1 year +/- 30 days post grafting
Secondary Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation Evaluation of efficacy at experimental area and control area, calculating the epithelialized area as percentage of the total grafted area. 28 +/- 3 days post grafting
Secondary Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take. Evaluation of efficacy at experimental area and control area, assessed by the analysis of the graft take 4-11 days post grafting
Secondary Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Pediatric quality of life inventory") 1 +/- 30 days year post grafting
Secondary Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Patient Observer Scar Assessment Scale") 1 +/- 30 days year post grafting
Secondary Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("EuroQuol 5 dimensions questionnaire") 1 +/- 30 days year post grafting
Secondary Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Burn Specific Health Scale Brief") 1 +/- 30 days year post grafting
Secondary Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate. Evaluation of safety at experimental area and control area based on the infection rate, assessed by using wound swabs and clinical evaluation. 4-11 days and 19-23 days post grafting
Secondary Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events. Evaluation of safety at experimental area and control area, assessed by the type and number of adverse events. through study completion, an average of 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT03947450 - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees Phase 2
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Active, not recruiting NCT03649308 - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting N/A
Recruiting NCT05984628 - Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds N/A
Completed NCT05112679 - Limb Health and Socket Pressure in Response to Powered Ankle Protheses N/A
Completed NCT03795116 - Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention Phase 2
Recruiting NCT04557761 - Comparison of microMend® Devices to Sutures in Closing Lacerations in Children N/A
Withdrawn NCT05643755 - Preoperative Image-based Education Effect on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery N/A
Completed NCT03754218 - Amnion Wound Covering for Enhanced Wound Healing Early Phase 1
Active, not recruiting NCT05517902 - StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects Phase 3
Terminated NCT03005054 - StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects Phase 2
Completed NCT06352853 - Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section N/A
Completed NCT03960164 - Dermal Regeneration Photosynthetic Matrix Early Phase 1