Clinical trials: Burn Injury
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
Burns
Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns
The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included.
- Trial name
- NCT01418482
- Testing
- Mepilex Border Ag
- Where
- 2 sites in Sweden
- Volunteers
- 15 people
- Sponsor
- Molnlycke Health Care AB
Weight Loss
Effect of Transform Burn on Weight Loss
This study was undertaken to explore the effects of a Thermogenic Composition (TC) composed of dihydrocapsiate, red pepper (Capsicum annuum) fruit extract, citrus (Citrus spp) peel extract, coleus (Coleus forskholi) root extract…
- Trial name
- Transform (NCT06092840)
- Testing
- Transform Burn
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- 4Life Research, LLC
Burns
Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries
After severe burn injury, the full-thickness burn areas are excised (in the first week) and then temporarily covered with allograft (cryogenic preserved cadaver skin).
- Trial name
- NCT00366041
- Testing
- Dermal substrate cellularised LG002 (10x10cm), Dermal substrate uncellularised LG002 (10x10 cm)
- Where
- 2 sites in France
- Volunteers
- 20 people
- Sponsor
- Laboratoires Genévrier
Fat Burn
Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue
This study will evaluate the safety and performance of the BTL-899 device for non-invasive treatment of subcutaneous fat. The changes in the fat tissue related to the activity of caspase-3 will be assessed histologically.
- Trial name
- NCT05139745
- Testing
- BTL-899
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- BTL Industries Ltd.
Burns
Allogenic Stem Cell Therapy in Patients With Acute Burn
Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae.
- Trial name
- NCT01443689
- Testing
- human umbilical cord mesenchymal stem cells, human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells, Conventional therapy
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
Wounds
Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.
- Trial name
- NCT00656474
- Testing
- GLYC-101 gel (1.0 %)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- TR Therapeutics
Wound Infection
Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients
The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage treatment of E. coli or P. aeruginosa wound infections in burned patients.
- Trial name
- PHAGOBURN (NCT02116010)
- Testing
- E. coli Phages cocktail, Standard of care : Silver Sulfadiazine, P. Aeruginosa, Phages cocktail
- Where
- 5 sites in Belgium, France and 1 more
- Sponsor
- Phagenix
Complicated Skin and Soft Tissue Infection
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
- Trial name
- NCT01499277
- Testing
- Ceftaroline fosamil, Vancomycin, Aztreonam
- Where
- 91 sites in United States, Argentina and 26 more
- Volunteers
- 802 people
- Sponsor
- Pfizer
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
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
The aim of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoadsorption using the Efferon® LPS device to reduce the severity of clinical symptoms and to prevent the progression…
- Trial name
- NCT07568132
- Testing
- Efferon LPS
- Where
- Russia
- Volunteers
- 50 people
- Sponsor
- Efferon JSC
Burn Wound, Pressure Ulcers Stage II
Study to Evaluate the Performance and Safety of the Medical Device Argogen
A wound, i.e., a break in the skin, can result from several reasons. Pressure ulcers (also called pressure sores, bed sores and decubitus ulcers) are localized damage to the skin and underlying soft tissue usually over a bony…
- Conditions
- Burn Wound, Pressure Ulcers Stage II, Pressure Ulcers Stage III
- Trial name
- NCT05649332
- Testing
- Argogen (silver zeolite powder)
- Where
- 2 sites in Romania
- Volunteers
- 58 people
- Sponsor
- Signorini Medicale S.r.l.
Deep Partial-thickness Burn
StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )
An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body.
- Trial name
- NCT04123548
- Testing
- StrataGraft skin tissue
- Where
- 10 sites in United States
- Volunteers
- 52 people
- Sponsor
- Stratatech, a Mallinckrodt Company
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
Fat Burn
Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation
This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment.
- Trial name
- NCT06274177
- Testing
- BTL-785-7
- Where
- 4 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- BTL Industries Ltd.
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
Sunburn
Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol
The purpose of this clinical trial is to evaluate the dermal safety of Bemotrizinol (6%).
- Trial name
- NCT05260359
- Testing
- 6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation, 6% Bemotrizinol (BEMT) dispersion in petrolatum, Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- dsm-firmenich Switzerland AG