Clinical trials: Surgical Injury
Bleeding, Surgical Wound
Traumacel FAM Trium in the Post-market Surveillance Phase
The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric.
- Trial name
- NCT05177874
- Testing
- Traumacel FAM Trium, Surgicel Fibrillar
- Where
- Czechia
- Volunteers
- 98 people
- Sponsor
- Bioster, a.s.
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Tibial Fracture
Assessment of the Verus Frame in Tibial Intramedullary Nailing
This prospective, single-arm Post-Market Clinical Follow-Up (PMCF) study, utilizing a registry-based control group, will assess the Verus frame's effectiveness in achieving precise tibial rotation and alignment during…
- Trial name
- NCT07362121
- Testing
- Verus frame to stabilize tibia
- Where
- Finland
- Volunteers
- 25 people
- Sponsor
- Hemitec Finland Oy
Surgical Site Infection
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
- Trial name
- NCT02255487
- Testing
- IrriSept System, No Intervention - Standard of Care (SoC) only
- Where
- 17 sites in United States
- Volunteers
- 627 people
- Sponsor
- Irrimax Corporation
Infection of Total Knee Joint Prosthesis
Evaluating Bactisure Wound Lavage in Orthopedic Wounds
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
- Trial name
- NCT03192124
- Testing
- Bactisure
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
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.
Anterior Cruciate Ligament Injuries
A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
- Trial name
- NCT05398341
- Testing
- The BEAR® Implant
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- Miach Orthopaedics
Cataract Extraction
Effect on Wound Healing of Vigamox Versus Cravit
The purpose of this study was to compare the effects of Vigamox and Cravit on corneal wound healing after cataract surgery.
- Trial name
- NCT00840580
- Testing
- Moxifloxacin 0.5% ophthalmic solution (Vigamox), Levofloxacin 0.5% ophthalmic solution (Cravit)
- Where
- South Korea
- Volunteers
- 79 people
- Sponsor
- Alcon Research
Bleeding, Surgical Wound
Traumacel PULVIS and Traumacel ENDO Applicator in the Post-market Surveillance Phase
Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to prevent bleeding in the early post-operative…
- Trial name
- NCT05177887
- Testing
- Traumacel PULVIS, Traumacel ENDO Applicator
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- Bioster, a.s.
Disorder of Skin and/or Subcutaneous Tissue of Trunk
Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive
The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and effective alternative to drains(standard of care) for fluid management following abdominoplasty.
- Trial name
- NCT01791504
- Testing
- TissuGlu Surgical Adhesive
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Cohera Medical, Inc.
Surgical Site Infection
DFA-02 in Patients Undergoing Colorectal Surgery
This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and…
- Trial name
- NCT01496352
- Testing
- DFA-02
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Scar, Incision
A Safety and Efficacy Study to Evaluate AIV001 in Wound Healing Following Surgical Incision
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds
- Conditions
- Scar, Incision, Abdominal, Wound (Morphologic Abnormality)
- Trial name
- NCT03639883
- Testing
- AIV001
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AiViva BioPharma, Inc.
Abdominoplasty
Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage
This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the…
- Trial name
- NCT01526954
- Testing
- TissuGlu Surgical Adhesive
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Cohera Medical, Inc.
Articular Cartilage Disorder, Degeneration; Articular Cartilage
Neocartilage Implant to Treat Cartilage Lesions of the Knee
ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to…
- Conditions
- Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury, Acute Cartilage Injury
- Trial name
- NCT01400607
- Testing
- Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft), Microfracture
- Where
- 9 sites in United States
- Volunteers
- 14 people
- Sponsor
- ISTO Technologies, Inc.
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
Injury of Ureter During Surgery (Disorder)
Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery
The goal of this clinical trial is to determine if the drug Nizaracianine Triflutate can help surgeons see and avoid the ureters during abdominopelvic surgery.
- Trial name
- TRIPHASE (NCT06101745)
- Testing
- Nizaracianine Triflutate
- Where
- 10 sites in United States, Netherlands
- Volunteers
- 336 people
- Sponsor
- Curadel Surgical Innovations, Inc.
Defect of Articular Cartilage, Articular Cartilage Disorder of Knee
the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee
The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.
- Conditions
- Defect of Articular Cartilage, Articular Cartilage Disorder of Knee, Degeneration; Articular Cartilage, Knee
- Trial name
- NCT02524509
- Where
- South Korea
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Kyphosis, Spinal Fractures
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
- Trial name
- LOADPRO (NCT02768675)
- Testing
- LOADPRO
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Intellirod Spine
Acute Kidney Injury
A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery
This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.
- Trial name
- NCT01777165
- Testing
- ABT-719
- Where
- 41 sites in United States, Denmark
- Volunteers
- 240 people
- Sponsor
- AbbVie
Hip Osteoarthritis, Rheumatoid Arthritis
G7 Dual Mobility With Vivacit-E or Longevity PMCF
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of…
- Conditions
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis
- Trial name
- NCT05548972
- Testing
- G7 Dual Mobility with Vivacit-E bearing, G7 Dual Mobility Longevity bearing
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 358 people
- Sponsor
- Zimmer Biomet