Clinical trials: Burn Injuries
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
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Burns, Wound Healing
A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns
Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a…
- Trial name
- NCT01636362
- Testing
- Mepitel Ag
- Where
- 6 sites in United States
- Volunteers
- 45 people
- Sponsor
- Molnlycke Health Care AB
Burns
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).
- Trial name
- NCT04090424
- Testing
- NovoSorb BTM, Standard of Care
- Where
- 26 sites in United States, India
- Volunteers
- 150 people
- Sponsor
- PolyNovo Biomaterials Pty 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
Leg Ulcer, Diabetic Foot Ulcer
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound
- Trial name
- GELFI (NCT05148390)
- Testing
- Cutimed® Gelling Fiber
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- BSN Medical GmbH
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
Critical Illness, Burns
Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.
- Conditions
- Critical Illness, Burns, Surgery, Urinary Tract Infections
- Trial name
- CAB (NCT03816384)
- Testing
- Standard of Care, DLC Group, DLCS Group
- Sponsor
- Potrero Medical
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
Safety and Efficacy of I-020502 in Meshed Skin Autografting
This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to…
- Trial name
- NCT00471939
- Testing
- I-020502
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Kuros Biosurgery AG
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
A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings
The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.
- Trial name
- NCT01067729
- Testing
- AWBAT Wound Dressing, AWBAT™, Biobrane®
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aubrey Inc.
Wounds and Injuries
Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing.
- Trial name
- NCT05424354
- Testing
- Altrazeal (R) Transforming Powder Dressing, Standard of Care burn dressing
- Where
- 6 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ULURU Inc.
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.
Burns
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.
- Trial name
- NCT01297400
- Testing
- Investigational Drug, MW-III, Silvadene® Cream 1% [Silver Sulfadiazine]
- Where
- 6 sites in United States, Mexico
- Volunteers
- 60 people
- Sponsor
- Skingenix, Inc.
Burn, Trauma
Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.
- Conditions
- Burn, Trauma, Varicose Ulcer
- Trial name
- NCT00426972
- Testing
- estradiol (Zesteem)
- Where
- 30 sites in Germany, Latvia and 2 more
- Volunteers
- 148 people
- Sponsor
- Renovo
Burn, Partial Thickness
Using Santyl or Bacitracin on Second Degree Burns
Subjects who have minor, second degree burns may be enrolled in this study. Subjects will receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals.
- Trial name
- NCT01516463
- Testing
- Collagenase Santyl, Bacitracin
- Sponsor
- Healthpoint
Thermal Injury, Deep Partial-Thickness Burn
Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds
The purpose of this research study is to test how well the investigational treatment, Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds.
- Conditions
- Thermal Injury, Deep Partial-Thickness Burn, Full-Thickness Burn
- Trial name
- NCT01655407
- Testing
- Autologous Engineered Skin Substitute, Split-Thickness Autograft (AG)
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Amarantus BioScience Holdings, Inc.
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
Bandages
Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects
The purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.
- Trial name
- NCT02353507
- Testing
- Opticell Ag+, Aquacel Ag+
- Sponsor
- Medline Industries