Clinical trials: Fractures, Open
Open tíbia Fracture
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
The Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries.
- Trial name
- BeadsvsVac (NCT05615844)
- Testing
- Antibiotic Cement Bead Pouch, Negative Pressure Wound Therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 312 people
- Sponsor
- University of Maryland, Baltimore
Open tíbia Fracture, Osteomyelitis Tibia
Intramedullary Calcium Sulfate Antibiotic Depot
The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate…
- Conditions
- Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures
- Trial name
- NCT05766670
- Testing
- Vancomycin Hydrochloride, Gentamicin, Standard Intramedullary Nail
- Where
- 12 sites in United States
- Volunteers
- 242 people
- Sponsor
- Wake Forest University Health Sciences
Condylar Process of Mandible Open Fracture
Assessment of Condylar Position With Management of Unilateral Mandibular Angle Fracture
The objective of this study is to assess condylar position and occlusion after open reduction and internal fixation using two miniplates versus patient specific plate
- Trial name
- NCT07858890
- Testing
- 2 mini plates, patient specific plates
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Cairo University
Trauma Injury, Trauma
OCT in Open Fracture and Infected Fracture
This is a pilot prospective, observational study of patients with open or infected fracture evaluating the feasibility and acceptability of OCT, a light-based imaging modality that requires no drug or contrast agent.
- Conditions
- Trauma Injury, Trauma, Open Fracture, Fracture Infection
- Trial name
- NCT05785182
- Testing
- Open Fracture, Infected Fracture
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Open Fracture
Placement of Antibiotic Powder in Wounds During the Emergency Room
This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department…
- Trial name
- POWDER (NCT03765567)
- Testing
- Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Open Tibia Fracture, Open Dislocation of Ankle
Accelerated Flap Coverage in Severe Lower Extremity Trauma
The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or…
- Conditions
- Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower
- Trial name
- FLAP ATTACK (NCT06293469)
- Testing
- Accelerated Flap Coverage Surgery, Standard of Care Flap Timing
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 356 people
- Sponsor
- Johns Hopkins University
Open Tibia Fracture, Open Dislocation of Ankle
Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or…
- Conditions
- Open Tibia Fracture, Open Dislocation of Ankle, Extremity Fracture Lower, Extremity Injuries Lower
- Trial name
- FLAP ATTACK (NCT07828613)
- Testing
- Accelerated Flap Coverage Surgery, Standard of Care Flap Timing
- Where
- 31 sites in United States
- Volunteers
- 356 people
- Sponsor
- Johns Hopkins University
Wound Infection, Fractures, Open
Tobramycin Injection to Prevent Infection in Open Fractures
The goal of open extremity fracture (OEF) treatment is to promote fracture healing and restore function while preventing the development of infection.
- Conditions
- Wound Infection, Fractures, Open, Surgical Site Infection
- Trial name
- NCT04964947
- Testing
- Tobramycin Injection
- Where
- 3 sites in United States
- Volunteers
- 600 people
- Sponsor
- Massachusetts General Hospital
Fractures, Bone, Nonunion of Fracture
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union…
- Conditions
- Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited
- Trial name
- NCT04299022
- Testing
- Vivigen Cellular Bone Matrix
- Where
- 4 sites in United States
- Volunteers
- 250 people
- Sponsor
- LifeNet Health
Fracture Open Tibia
Gentamicin Open Tibia Study
Local application of antibiotics directly to the traumatic wound is a promising treatment for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in…
- Trial name
- GO-Tibia (NCT05157126)
- Testing
- Gentamicin, normal Saline
- Where
- Tanzania
- Volunteers
- 890 people
- Sponsor
- University of California, San Francisco
Open Tibia Fracture
Low-cost Negative Pressure Wound Therapy vs Standard Dressings for Gustilo IIIb Tibial Fractures (Bukavu Pilot RCT)
Negative-pressure wound therapy (NPWT) is widely used in the management of acute and chronic wounds, but commercial systems are costly and may be inaccessible in low-resource settings.
- Trial name
- BukavuNPWTRC (NCT07790991)
- Testing
- intervention2: standard wound dressing, Intervention1: Low-cost NPWT
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 66 people
- Sponsor
- Université Catholique de Bukavu
Surgery Complications, Surgery
SurgWeek-2: Identifying the Global Burden of Post Operative Complications: an International Prospective Cohort Study Protocol
This study aims to assess and improve the global outcomes following surgery. Every year approximately 313 million operations are performed, with 50 million people experiencing a complication and unfortunately 3.5 million people…
- Conditions
- Surgery Complications, Surgery, Global Surgery, Robotic
- Trial name
- SurgWeek-2 (NCT07785076)
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- University of Birmingham
Osteomyelitis Tibia, Tibial Fractures
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
- Conditions
- Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture
- Trial name
- NCT05421741
- Testing
- Antibiotic coated intramedullary Nail, Standard Intramedullary Nail
- Where
- 15 sites in United States
- Volunteers
- 242 people
- Sponsor
- Wake Forest University Health Sciences
Wounds, Wounds and Injuries
Pilot Trial for WounDx™ Clinical Decision Support Tool
The purpose of this research is to evaluate the overall use of the WounDx medical device in a clinical setting, such as a hospital.
- Conditions
- Wounds, Wounds and Injuries, Extremity Injury, Traumatic Wounds and Injuries
- Trial name
- NCT06921707
- Testing
- Clinical Decision Support Tool, Standard of Care (SOC)
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Trauma Injury
ICG Fluorescence Imaging in Open Fracture Trauma Patients
This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and complications, in an effort to develop ICG…
- Trial name
- NCT04416412
- Testing
- Immunofluorescence Imaging
- Where
- 4 sites in United States
- Volunteers
- 124 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Fractures, Open
The Treatment of Type I Open Fractures in Pediatrics
Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated.
- Trial name
- PROOF (NCT00870064)
- Testing
- Formal Operative Treatment, Emergency Department Treatment
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Open Fracture
Implementation of Vancomycin Powder Application in the Emergency Department for Open Fractures
To evaluate the feasibility, safety, and potential efficacy of applying vancomycin powder locally to open fractures in the emergency department prior to definitive surgical intervention.
- Trial name
- NCT07659886
- Testing
- Vancomycin (VAN) treatment, Standard Open Fracture Care
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Atlantic Health System
Severe Open Fractures of the Tibia (Shin) Bone
Assessment of Fixation Strategies for Severe Open Tibia Fractures
The purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures.
- Trial name
- FIXIT (NCT01494519)
- Testing
- Surgery with an external ring fixator, Definitive fixation with a locked IM nail or plate
- Where
- 33 sites in United States
- Volunteers
- 442 people
- Sponsor
- Major Extremity Trauma Research Consortium
Open Fracture
Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
The purpose of this study is to characterize the bacteria in the wound "bioburden" at the time of definitive wound coverage/closure of severe tibia fractures in both the military and civilian populations.
- Trial name
- Bioburden (NCT01496014)
- Where
- 40 sites in United States
- Volunteers
- 646 people
- Sponsor
- Major Extremity Trauma Research Consortium
Open Fracture
Volume Reduction for Open Fracture Irrigation
The purpose of this study is to help doctors who treat open fractures understand how much fluid is required when cleaning out the wound.
- Trial name
- NCT07437339
- Testing
- 0.9% Sodium Chloride
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Inova Health Care Services