Clinical trials: Burn
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
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
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
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
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
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
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
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
Thermal Burns
A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are: 1.
- Trial name
- NCT02148705
- Testing
- NexoBrid, Standard of Care (SOC), Gel Vehicle
- Where
- 29 sites in United States, Belgium and 6 more
- Volunteers
- 175 people
- Sponsor
- MediWound 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
Wounds
Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide…
- Trial name
- NCT00792688
- Testing
- GLYC-101 Gel (0.1%), GLYC-101 Gel (1.0%)
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- TR Therapeutics
Hematologic Neoplasms, Burns
Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital
The overall objective of this study is to collect preliminary safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with burns and patients with hematological malignancies.
- Trial name
- NCT05549232
- Testing
- Hypoxic Red Blood Cells
- Where
- Norway
- Volunteers
- 22 people
- Sponsor
- Hemanext
Infections, Gram-positive Bacterial
Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to…
- Trial name
- FAST2 (NCT00077675)
- Testing
- Telavancin, vancomycin or antistaphylococcal penicillin
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Cumberland Pharmaceuticals
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Restrictive Burn Scars
Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to determine whether injection of autologous fibroblasts can increase the mobility (decrease the restriction) of burn scars.
- Trial name
- NCT01858753
- Testing
- Autologous fibroblasts
- Where
- 9 sites in United States
- Volunteers
- 5 people
- Sponsor
- Castle Creek Biosciences, LLC.
Burns
Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.
- Trial name
- NCT01657292
- Testing
- Oleogel-S10 ointment, Octenilin® wound gel
- Where
- 9 sites in Germany, Sweden and 2 more
- Volunteers
- 61 people
- Sponsor
- Birken AG
Inflammation, Burns
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
The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers)…
- Conditions
- Inflammation, Burns, Ulcers
- Trial name
- NCT01214811
- Testing
- Mepilex Border Ag
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Molnlycke Health Care AB
Burn Wound
A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG
Burn patients meeting inclusion criteria will receive the esterified hyaluronic acid matrix as the matrix for their wound, in conjunction with the standard of care for managing these types of wounds.
- Trial name
- NCT03723590
- Testing
- Esterified Hyaluronic Acid Matrix
- Volunteers
- 5 people
- Sponsor
- Medline Industries
Third Degree Burn, Burns
StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
This pilot Phase I/II clinical study will be conducted at up to three clinical sites. This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects.
- Conditions
- Third Degree Burn, Burns, Wound Infection, Degloving Injury
- Trial name
- NCT00618839
- Testing
- StrataGraft Skin Tissue, Cadaver allograft
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Burns
RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a…
- Trial name
- NCT03626701
- Testing
- RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Mepilex® Ag Wound Dressing, Conventional autografting (only when indicated)
- Where
- 9 sites in United States
- Volunteers
- 19 people
- Sponsor
- Avita Medical