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Fractures, Open clinical trials

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NCT ID: NCT05267977 Suspended - Clinical trials for Lower Extremity Fracture

Antibiotic Use & Open Fracture of the Lower Extremity

Start date: August 2016
Phase: Phase 1/Phase 2
Study type: Interventional

It is important to recognize the potential for renal injury and be cognizant of this during the management of complex trauma patients. The primary aim of this study is to investigate the necessity of aminoglycoside usage for patients with open lower extremity fractures. Hypothesis: adding aminoglycoside on top of cephalosporin in treating lower extremity fracture will make no significant difference in term of clinical outcomes when compared to cephalosporin alone.

NCT ID: NCT05260463 Recruiting - Clinical trials for Surgical Site Infection

LOQTEQ® Antibacterial Pre-Market Study

Start date: December 9, 2021
Phase: N/A
Study type: Interventional

aap001 is a randomized, controlled, subject-blinded, multi-center study to show the safety of the LOQTEQ® antibacterial silver-coated system is non-inferior in comparison with the uncoated LOQTEQ® system

NCT ID: NCT05157126 Recruiting - Fracture Open Tibia Clinical Trials

Gentamicin Open Tibia Study

GO-Tibia
Start date: September 1, 2022
Phase: Phase 4
Study type: Interventional

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 low-income countries. This study aims 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: NCT05006313 Not yet recruiting - Clinical trials for Intraoperative Fluorescence Angiography

Intraoperative Fluorescence Angiography in Debridement of Open Fractures

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The proposed research aims to be a pilot feasibility study to evaluate intraoperative fluorescence angiography (IFA) as an aid for acute debridement in orthopaedic trauma.

NCT ID: NCT04964947 Recruiting - Clinical trials for Surgical Site Infection

Tobramycin Injection to Prevent Infection in Open Fractures

Start date: January 10, 2022
Phase: Phase 3
Study type: Interventional

The goal of open extremity fracture (OEF) treatment is to promote fracture healing and restore function while preventing the development of infection. This is achieved through systematic and timely wound debridement and irrigation, fracture stabilization, tetanus prophylaxis, systemic and local antimicrobial therapy, and judicious timing of wound closure based on cleanliness. Early prophylactic systemic antibiotics lower infection rates in open fractures but have limitations of achieving adequate concentration at the hypoperfused wound area. OEF wounds are frequently poor in vasculature secondary to the soft tissue injury, hence adequate concentration of antibiotic cannot permeate to the tissue at risk. If systemic antibiotic concentrations are increased to achieve minimum inhibitory concentration (MIC) for pathogens at the wound, there is heightened concern for systemic drug toxicity. In sharp contrast, locally administered antibiotics achieve high drug concentration directly within the wound cavity with minimal systemic side effects. Local antibiotic therapy has shown to reduce rates of open fracture wound infection. With the serious implications of postoperative infections in OEF, it is imperative that all measures including further use of prophylactic local antibiotics be considered to prevent fracture-related infection (FRI). The overarching hypothesis for this project is that a novel synergistic combination of local aqueous tobramycin plus perioperative weight-based IV cephalosporin antibiotic prophylaxis will reduce the rate of FRI one year after OEF surgery. This in turn will improve OEF patient outcomes, decreasing morbidity and return to the operating room (OR) without any adverse effect on fracture healing. Regardless of the treatment group, bacterial speciation will be determined for patients that do develop FRI to help guide future treatment. The goal is to improve the clinical outcome and recovery of the population that sustains an OEF by decreasing the rate of FRI and fracture nonunions while concurrently educating on bacterial speciation and resistance.

NCT ID: NCT04872400 Completed - Fractures, Bone Clinical Trials

Acute Application of Antibiotic Powder in Open Fracture Wounds

APOW
Start date: June 14, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds. Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.

NCT ID: NCT04730739 Recruiting - Fracture Clinical Trials

FastFrame Knee Spanning and Damage Control Kit PMCF

Start date: June 18, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.

NCT ID: NCT04678154 Recruiting - Clinical trials for Post Operative Surgical Site Infection

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT

Start date: May 7, 2021
Phase: Phase 3
Study type: Interventional

The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.

NCT ID: NCT04551157 Terminated - Major Trauma Clinical Trials

Impact of Psychoeducational Video on Adjustment to Open Fracture.

Start date: December 3, 2020
Phase: N/A
Study type: Interventional

The multi-disciplinary team involved in the care of major trauma patients with open fractures has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. The experiences of previous patients are also included. The aim of this project is to evaluate the impact of viewing these videos on patients' ability to follow treatment recommendations made by the team, as well as their psychological and social functioning, as measured by standardised questionnaire responses. Additionally, the patient's experience of viewing the videos, in terms of how relevant and useful they found them, will be evaluated.

NCT ID: NCT04481269 Not yet recruiting - Clinical trials for Open Fractures, Degenerative Osteoarthritis and Degenerative Spinal Diseases

A Prospective Randomized Controlled Study on the Clinical Efficacy of a New Surface Modified Composite Coating Orthopedic Implant Device

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

This study is a prospective, randomized, controlled, double-arm, non-inferiority study that will be carried out in China. It aims to compare two implant systems (the research group uses surface-modified composite coated orthopedic implants, and controls group using conventional orthopedic implants) safety and effectiveness. A total of 240 patients were recruited. The recruited patients are randomly divided into groups at a ratio of 1:1 to ensure that the distribution of patients in the treatment group and the control group is consistent. Patients will receive clinical follow-up in the 1, 3, 6, 9 and 12 months postoperatively. The main indicator for evaluation is the postoperative infection rate, and the secondary indicators include the SF-12 scoring scale, EQ-5D patient questionnaire score, fracture healing, malunion, nonunion incidence in the 12th month after surgery, and skin and soft tissue complications Symptom incidence rate. The follow-up data will be used to determine the main safety and effectiveness of the new surface modified composite coated orthopedic implant system.