Clinical trials: Skin Injury
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
Breast Cancer
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy
The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality…
- Trial name
- PRECISE (NCT00960154)
- Testing
- PEAK PlasmaBlade, Traditional Electrosurgery with scalpel
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Surgical Technologies
Diabetic Foot Ulcers, Diabetic Foot Wounds
Wound Edge Changes Following Treatment With Santyl
The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds following 14 days of treatment with Santyl or its vehicle base.
- Trial name
- NCT01197898
- Testing
- Collagenase Santyl Ointment
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Healthpoint
Osteoarthritis, Hip, Fracture of Hip
Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2.
- Conditions
- Osteoarthritis, Hip, Fracture of Hip, Avascular Necrosis of Hip, Dislocated Hip
- Trial name
- NCT04079114
- Testing
- Patients who received the Stafit Acetabular System
- Volunteers
- 166 people
- Sponsor
- Zimmer Biomet
Venous Leg Ulcers
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Trial name
- NCT01737762
- Testing
- HP802-247, Vehicle
- Where
- 43 sites in United States, Canada and 1 more
- Volunteers
- 155 people
- Sponsor
- Healthpoint
Lung Diseases, Obstructive, Sarcoidosis
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid…
- Conditions
- Lung Diseases, Obstructive, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma
- Trial name
- ICEtheBAD (NCT00747461)
- Testing
- CryoSpray Ablation
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- CSA Medical, Inc.
Foot Ulcer, Diabetic
A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
The primary objective is to: Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.
- Trial name
- NCT01013792
- Testing
- Wound Dressing
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Solventum US LLC
Diabetic Foot Ulcer
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the…
- Trial name
- NCT02181621
- Testing
- Iodosorb, Solosite gel
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer
Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU).
- Trial name
- NCT01113515
- Testing
- Esmolol hydrochloride
- Where
- 5 sites in United States, India and 1 more
- Volunteers
- 44 people
- Sponsor
- Novalead Pharma Private Limited
Diabetic Foot Ulcer
MIRODERM H2H DFU Study
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
- Trial name
- H2H-DFU (NCT03232333)
- Testing
- Biologic wound graft
- Where
- 9 sites in United States
- Volunteers
- 53 people
- Sponsor
- Miromatrix Medical Inc.
Venous Ulcer, Venous Stasis Ulcer
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Conditions
- Venous Ulcer, Venous Stasis Ulcer, Ulcer
- Trial name
- NCT01853384
- Testing
- HP802-247, HP802-247 Vehicle
- Where
- 46 sites in Belgium, Czechia and 3 more
- Volunteers
- 252 people
- Sponsor
- Healthpoint
Wounds
Evaluation of Skin Affix in the Emergency Room
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
- Trial name
- NCT02223689
- Testing
- Skin Affix
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Medline Industries
Abscess, Wound Infection
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a…
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Trial name
- NCT01431339
- Testing
- IV Dalbavancin, Vancomycin/Linezolid
- Where
- 137 sites in United States, Bulgaria and 12 more
- Volunteers
- 739 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
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
Diabetic Foot Ulcers, Pressure Ulcers
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
- Trial name
- NCT00971048
- Testing
- HP828-101, Hydrogel/Hydrocolloid
- Where
- 11 sites in United States
- Volunteers
- 88 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan).
- Trial name
- TRANS-South (NCT01217463)
- Testing
- Trafermin 0.01% spray
- Where
- 24 sites in Czechia, France and 2 more
- Volunteers
- 201 people
- Sponsor
- Olympus Biotech Corporation
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Lacerations
Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department.
- Trial name
- NCT00547638
- Testing
- cyanoacrylate with pressure sensitive mesh, cyanoacrylate
- Where
- 9 sites in United States
- Volunteers
- 216 people
- Sponsor
- Ethicon, Inc.