Clinical trials: Burn
Septic Shock, Acute Respiratory Distress Syndrome
CytOSorb TreatMent Of Critically Ill PatientS Registry
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based…
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma, Rhabdomyolysis
- Trial name
- COSMOS (NCT05146336)
- Testing
- CytoSorb
- Where
- 28 sites in Austria, Germany and 4 more
- Volunteers
- 3,000 people
- Sponsor
- CytoSorbents, Inc
Burns
Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns
This observational pilot study aims to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury.
- Trial name
- NCT07248930
- Testing
- Efferon LPS NEO
- Where
- 2 sites in Russia
- Sponsor
- Efferon JSC
Burns, Burn Injury
Deepview HHF Training and Validation Study
The purpose of this Study is to help expand the use of the DeepView AI System so that it can assess burn injuries on the hands, head/face, and feet. To do this, the Study will collect new images of burns in these areas.
- Conditions
- Burns, Burn Injury, Diagnostic
- Trial name
- UK HHF (NCT07677657)
- Testing
- DeepView AI System
- Volunteers
- 280 people
- Sponsor
- SpectralMD
Burn Scar, Burn Wound
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery.
- Trial name
- NCT06807021
- Testing
- IP1 control cream (Vehicle base), IP2 - 0.5% w/w FS2
- Where
- 2 sites in Canada
- Volunteers
- 70 people
- Sponsor
- Birch BioMed Inc
Surgical Wound, Trauma Wound
Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds
The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound.
- Conditions
- Surgical Wound, Trauma Wound, Autografts, Partial-thickness Burn
- Trial name
- NCT06750809
- Testing
- PermeaDerm Biosynthetic Wound Matrix, Frozen Human Cadaveric Allograft (FHCA)
- Where
- 13 sites in United States
- Volunteers
- 40 people
- Sponsor
- Avita Medical
Burn, Trauma Wound
Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds
The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds.
- Conditions
- Burn, Trauma Wound, Full Thickness Wounds, Surgical Wound
- Trial name
- Cohealyx I (NCT06787690)
- Testing
- Cohealyx
- Where
- 18 sites in United States
- Volunteers
- 41 people
- Sponsor
- Avita Medical
Burns
Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in…
- Trial name
- NCT06745557
- Testing
- denovoSkin(TM), STSG
- Where
- 19 sites in Belgium, France and 7 more
- Volunteers
- 70 people
- Sponsor
- CUTISS AG
Burns
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.
- Trial name
- NCT03227146
- Testing
- EHSG-KF, STSG
- Where
- 6 sites in Italy, Netherlands and 1 more
- Volunteers
- 14 people
- Sponsor
- CUTISS AG
Burns
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
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.
- Trial name
- NCT03229564
- Testing
- EHSG-KF, STSG
- Where
- 4 sites in Italy, Netherlands and 1 more
- Volunteers
- 12 people
- Sponsor
- CUTISS AG
Burns
An Investigation of Performance and Safety of the Wound Dressing FibDex in Patients With Superficial Dermal Burns
This is a prospective, randomised, open-label, within-patient controlled, non-inferiority clinical investigation of the nanofibrillar cellulose (NFC) wound dressing FibDex® for treatment of superficial dermal burns in paediatric…
- Trial name
- NCT05629091
- Testing
- FibDex, Epicite hydro, Epiprotect
- Where
- Sweden
- Volunteers
- 7 people
- Sponsor
- UPM-Kymmene Corporation
Skin Scars, Post-burn Scars
Exploratory Study to Evaluate the Efficacy of the Cosmetic Product RV3895A on Re-epidermised Scars Following Burns and Surgical Stitches in Adults, Adolescents and Children Over a 6-month Follow-up Period
This study is exploratory, non-comparative and open-label, conducted in France. It aims to provide insights into the effectiveness and safety of RV3895A - RY1774, potentially benefiting participants by improving scar appearance…
- Conditions
- Skin Scars, Post-burn Scars, Post-surgical-stitches Scars
- Trial name
- NCT07020507
- Testing
- Product gel RV3895A
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Pierre Fabre Dermo Cosmetique
Burns, Wound Heal
Burn Validation Study
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.
- Conditions
- Burns, Wound Heal, Wounds and Injuries
- Trial name
- BVS (NCT06131203)
- Testing
- DeepView SnapShot Portable (DV-SSP)
- Where
- 21 sites in United States
- Volunteers
- 274 people
- Sponsor
- SpectralMD
Skin Wound, Burns
StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for DPT burns.
- Conditions
- Skin Wound, Burns, Trauma-related Wound
- Trial name
- StrataSTEPS (NCT05517902)
- Testing
- StrataGraft
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Burns
ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries.
- Trial name
- NCT02380612
- Testing
- ReCell Treatment, Skin Graft
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Avita Medical
Partial-thickness Burn
Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial…
- Trial name
- NCT04839523
- Testing
- Exufiber, Exufiber Ag+
- Where
- 6 sites in United States
- Volunteers
- 44 people
- Sponsor
- Molnlycke Health Care AB
Thermal Burns
A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns.
- Trial name
- NCT02278718
- Testing
- NexoBrid, Standard of Care
- Where
- 36 sites in United States, Belgium and 12 more
- Volunteers
- 145 people
- Sponsor
- MediWound Ltd
Thermal Burn
Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries
Enzymatic eschar removal with NexoBrid allows initiating and completing the phase of removal of the offending eschar earlier upon admission, enabling earlier visualization of the wound bed for assessment of burn wound depth as…
- Trial name
- NEXT (NCT04040660)
- Testing
- NexoBrid
- Where
- 28 sites in United States
- Sponsor
- MediWound Ltd
Partial-thickness Burn
Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns
A randomized, controlled, 30-subject, within-subject trial for examining the effectiveness of KeraStat Gel, as opposed to the institutional standard of care, silver sulfadiazine, in improving cosmesis of the healed wound.
- Trial name
- NCT03564795
- Testing
- KeraStat Gel, Silver Sulfadiazine
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- KeraNetics, LLC
Burns
CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries
The overall purpose of this is study to provide continued access to the ReCell device following completion of protocol CTP001-6, and allow for collection of supplementary clinical outcome data for the ReCell device when used as…
- Trial name
- NCT02994654
- Testing
- ReCell
- Where
- 6 sites in United States
- Volunteers
- 12 people
- Sponsor
- Avita Medical
Burns
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review.
- Trial name
- NCT03333941
- Testing
- ReCell® Autologous Cell Harvesting Device
- Where
- 6 sites in United States
- Volunteers
- 76 people
- Sponsor
- Avita Medical