Clinical trials: Burn Injuries
Burn
Altrazeal Range of Motion Study Comparing With Typical Carboxymethyl
The objective of this study is to evaluate the difference in joint range of motion of a new flexible hydrogel nanoparticle wound dressing compared to typical sodium carboxymethylcellulose dressing Aquacel AG for treatment of…
- Trial name
- ROM (NCT01062191)
- Testing
- Aquacel AG, typical carboxymethylcellulose dressing, Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- ULURU Inc.
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
Cancer, Breakthrough Pain
Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain (BTP) compared to placebo treatment in children with cancer and non-cancer pain who are receiving…
- Trial name
- NCT00236041
- Testing
- ACTIQ®
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 38 people
- Sponsor
- Cephalon
Burn Wound
Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
The primary purpose of this first-in-human, early feasibility study is to assess safety and feasibility of the Low-Irradiance Monochromatic Biostimulation (LIMB) System as a phototherapeutic intervention for the management of…
- Trial name
- NCT03948360
- Testing
- Low-Irradiance Monochromatic Biostimulation (LIMB) Device, Standard of Care
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Rogers Sciences Inc.
Burn Injuries
Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.
The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in…
- Trial name
- NCT01439074
- Testing
- Mepilex Ag, Silver Sulphadiazine Ag cream
- Where
- 9 sites in China
- Volunteers
- 162 people
- Sponsor
- Molnlycke Health Care AB
Thermal Burn
Feasibility of Obtaining ADRCs From Discarded Thermal Burn Eschar Tissue Using Investigational Celution® System
The objective of the study is to assess the logistical and biological feasibility of preparing ADRCs from adipose tissue excised during standard-of-care burn wound excision using the Celution® System for autologous, same-day…
- Trial name
- NCT02362386
- Testing
- Celution Device
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Cytori Therapeutics
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
Thermal Burn
Evaluation of the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag®
A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited. Subjects will be randomized (1:1) to either PermeaDerm® or Mepilex Ag®.
- Trial name
- NCT05084183
- Testing
- PermeaDerm®, Mepilex Ag
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Stedical Scientific, Inc.
Burns
Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours…
- Trial name
- NCT00606489
- Testing
- Caldolor
- Where
- 5 sites in United States, India
- Volunteers
- 61 people
- Sponsor
- Cumberland Pharmaceuticals
Burns
Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases
This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-epithelialization) as a treatment of…
- Trial name
- NCT02992249
- Where
- 22 sites in United States
- Volunteers
- 100 people
- Sponsor
- Avita Medical
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
Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds
The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds.
- Trial name
- NCT00161759
- Testing
- Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin
- Where
- 12 sites in United States
- Volunteers
- 40 people
- Sponsor
- Baxter Healthcare Corporation
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
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
Sunburn
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms
Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil…
- Trial name
- NCT01085851
- Testing
- Dexchlorpheniramine 1% lotion, Dexchlorpheniramine 1% cream
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
Donor Site Complication
An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients
The investigator will identify the test donor site and test location will be considered on the upper anterior thighs as being the most suitable if available. Circumferential donors will be considered acceptable as well.
- Trial name
- NCT01670201
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Molnlycke Health Care AB
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
Chronic Pain
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.
- Trial name
- NCT01206907
- Testing
- oxymorphone IR
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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
Limbal Stem Cells Deficiency
Efficacy and Safety of Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for Restoration of Corneal Epithelium in Patients With Limbal Stem Cell Deficiency
The purpose of this trial is to confirm the efficacy of Holoclar at one year after the first treatment in patients suffering from moderate to severe LSCD (Limbal Stem Cell Deficiency) secondary to ocular burns.
- Trial name
- HOLOCORE (NCT02577861)
- Testing
- Biopsy from donor eye, Implant of Holoclar, Ophtalmologic examination
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Holostem s.r.l.