Clinical trials: Skin 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
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
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
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
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
Skin Wound, Burns
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness…
- Conditions
- Skin Wound, Burns, Trauma-related Wound
- Trial name
- NCT01437852
- Testing
- StrataGraft Skin Tissue
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Infections, Gram-Positive Bacterial, Abscess
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. One of the ways to deal with this problem is to develop new drugs that can control these bacteria.
- Conditions
- Infections, Gram-Positive Bacterial, Abscess, Burns, Cellulitis
- Trial name
- FAST (NCT00061633)
- Testing
- Telavancin, Vancomycin or antistaphylococcal penicillin
- Where
- United States
- Volunteers
- 169 people
- Sponsor
- Cumberland Pharmaceuticals
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
Trauma-related Wound, Burns
StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.
- Conditions
- Trauma-related Wound, Burns, Skin Wound
- Trial name
- NCT03005054
- Testing
- StrataGraft Skin Tissue, Autograft
- Where
- 4 sites in United States
- Volunteers
- 3 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Burn Injury, Skin Graft
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn…
- Trial name
- MpTAg03 (NCT02210208)
- Testing
- Mepitel® Ag, Mepilex® Transfer Ag
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Molnlycke Health Care AB
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
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
Burns, Trauma
Split Thickness Donor Site Healing With MIST Study
Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split thickness donor sites expected to be between 20 and 200 square cm will be consecutively screened for study eligibility.
- Conditions
- Burns, Trauma, Venous Ulcers
- Trial name
- NCT01214980
- Testing
- MIST Therapy, Standard of care
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Celleration, Inc.
Burns
Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries
This is a multi-center, single arm, traditional feasibility study to allow a preliminary assessment of the safety and effectiveness of a new method of treating skin burns using Biodegradable Temporizing Matrix (BTM).
- Trial name
- NCT02905435
- Testing
- Biodegradable Temporizing Matrix
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- PolyNovo Biomaterials Pty Ltd.
Burn, Thermal
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat. The burns will: be on 3-49% of the participant's total body surface area (TBSA) require surgery for skin replacement…
- Trial name
- NCT03005106
- Testing
- StrataGraft Skin Tissue, Autograft
- Where
- 16 sites in United States
- Volunteers
- 71 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Deep Partial Thickness Burn, Full Thickness Burns
Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised…
- Trial name
- NCT01365273
- Testing
- Mepitel One
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Molnlycke Health Care AB