Clinical trials: WOUNDS INJURIES
Surgical Wound
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites.
- Trial name
- RESPECT (NCT01297322)
- Testing
- Manual compression, Cardiva VASCADE™ Vascular Closure System
- Where
- 21 sites in United States, Australia
- Volunteers
- 420 people
- Sponsor
- Cardiva Medical, Inc.
Iliac Artery Occlusive Disease
A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease
- Trial name
- Luminexx (NCT00561457)
- Testing
- Bard Luminexx Iliac Stent and Delivery System
- Volunteers
- 134 people
- Sponsor
- C. R. Bard
Traumatic Brain Injury
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
- Trial name
- NCT00893789
- Testing
- Armodafinil
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 117 people
- Sponsor
- Cephalon, Inc.
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
Urethral Stricture
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).
- Trial name
- ROBUST-III (NCT03499964)
- Testing
- Optilume Drug Coated Balloon (DCB), Control Treatment
- Where
- 22 sites in United States, Canada
- Volunteers
- 127 people
- Sponsor
- Urotronic Inc.
Subdural Hematoma, Chronic
The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for…
- Trial name
- STEM (NCT04410146)
- Testing
- SQUID Embolization, SQUID Embolization and Surgical Evacuation, Surgical Evacuation
- Where
- 32 sites in United States, France and 2 more
- Volunteers
- 319 people
- Sponsor
- Balt USA
Lung Cancer, Lung Cancer Metastatic
ANET Electrosurgery Applicator Pilot Evaluation Study
Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.
- Trial name
- NCT03400748
- Testing
- RF Ablation
- Where
- 4 sites in United States, Canada
- Volunteers
- 6 people
- Sponsor
- Olympus Corporation of the Americas
Femoral Fractures
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery.
- Trial name
- NCT00824564
- Testing
- Tranexamic Acid plus standard of care, Standard of care
- Where
- India
- Volunteers
- 82 people
- Sponsor
- Pfizer
Soft Tissue Injuries
Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants With Minor Soft Tissue Injury
A multi-center, prospective, open-label, controlled study of the pharmacokinetics and safety of the LicartTM topical system in pediatric and adult participants with minor soft tissue injuries.
- Trial name
- NCT05171673
- Testing
- Licart™ (diclofenac epolamine) topical system
- Where
- 11 sites in United States
- Volunteers
- 151 people
- Sponsor
- IBSA Institut Biochimique SA
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
Fracture, Fractures, Bone
FastFrame Knee Spanning and Damage Control Kit PMCF
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
- Conditions
- Fracture, Fractures, Bone, Fractures, Closed, Fractures, Open
- Trial name
- NCT04730739
- Testing
- FastFrame External Fixation System - Knee Spanning or Damage Control Kit
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Zimmer Biomet
Arteriovenous Fistula
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation…
- Trial name
- NCT01806545
- Testing
- SRM003, Participating Site's standard practice
- Where
- 47 sites in United States
- Volunteers
- 64 people
- Sponsor
- Shire
Brain Injuries, Growth Hormone Deficiency
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
- Trial name
- NCT00555009
- Testing
- Genotropin
- Where
- 9 sites in France, Italy and 4 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North 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-North (NCT01217476)
- Testing
- Trafermin 0.01% spray
- Where
- 37 sites in Belgium, Bulgaria and 8 more
- Volunteers
- 207 people
- Sponsor
- Olympus Biotech Corporation
Spinal Duraplasty
Adherus™ Dural Sealant in Spinal Procedures
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures.
- Trial name
- NCT04498026
- Testing
- Adherus Dural Sealant System, DuraSeal Exact Dural Sealant System
- Where
- 14 sites in United States
- Volunteers
- 94 people
- Sponsor
- Stryker Craniomaxillofacial
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
Post Surgical Incisions From Abdominoplasty Procedures
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.
- Trial name
- Mona Lisa (NCT00766727)
- Testing
- GLYDe Dressing
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neodyne Biosciences, Inc.
Wounds
The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04% when used as an antiseptic agent and to compare these with Ringers' solution in patients with acute traumatic wounds.
- Trial name
- Lavasept 2 (NCT01153620)
- Testing
- Lavasept 0.04%, Ringer's Solution
- Where
- Switzerland
- Volunteers
- 61 people
- Sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
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
Cancer, Hematologic Malignancies
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
- Conditions
- Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology
- Trial name
- NCT01345019
- Testing
- Denosumab, Zoledronic acid, Denosumab (for the open-label treatment phase)
- Where
- 309 sites in United States, Australia and 27 more
- Volunteers
- 1,718 people
- Sponsor
- Amgen