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Open tíbia Fracture clinical trials

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NCT ID: NCT06293469 Not yet recruiting - Clinical trials for Extremity Fracture Lower

Accelerated Flap Coverage in Severe Lower Extremity Trauma

FLAP ATTACK
Start date: July 2024
Phase: N/A
Study type: Interventional

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 dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).

NCT ID: NCT06288139 Not yet recruiting - Open tíbia Fracture Clinical Trials

Management of Open Fracture Tibia in Teenagers

Start date: March 1, 2024
Phase:
Study type: Observational

The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes

NCT ID: NCT05766670 Not yet recruiting - Tibial Fractures Clinical Trials

Intramedullary Calcium Sulfate Antibiotic Depot

Start date: June 2024
Phase: Phase 3
Study type: Interventional

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 antibiotic depot is better at preventing infection that the standard of care.

NCT ID: NCT05615844 Recruiting - Open tíbia Fracture Clinical Trials

Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

BeadsvsVac
Start date: November 5, 2023
Phase: Phase 3
Study type: Interventional

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. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. This is a Phase III trial.

NCT ID: NCT05421741 Recruiting - Tibial Fractures Clinical Trials

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Start date: May 15, 2023
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04072094 Not yet recruiting - Open tíbia Fracture Clinical Trials

Minimally Invasive Locking Plate Fixation vs Reamed Intramedullary Nail Fixation on Patients With Open Tibia Fracture

Start date: June 2020
Phase: N/A
Study type: Interventional

The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.

NCT ID: NCT03559400 Completed - Open Tibia Fracture Clinical Trials

Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania

pGO-Tibia
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

Local application of antibiotics directly to the traumatic wound is a promising strategy for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This pilot study aims to assess feasibility of a randomized controlled trial to measure the effect of locally applied gentamicin on risk of infection for open tibial fractures in Tanzania. If proven effective, local gentamicin would be a highly cost-effective strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.

NCT ID: NCT02064595 Completed - Open tíbia Fracture Clinical Trials

Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail

Start date: January 2011
Phase: N/A
Study type: Interventional

The objective of this research is to prospectively evaluate a group of patients with shaft compound fracture of the tibia, treated with a biplanar external fixator or locked intramedullary reamed nail. The investigators evaluate the quality of life, bone healing and postoperative complications.