Tobramycin Injection to Prevent Infection in Open Fractures

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04964947
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Arun Aneja, MD, PhD
Phone	617-726-6546
Email	aaneja@mgh.harvard.edu
Status	Recruiting
Phase	Phase 3
Start date	January 10, 2022
Completion date	September 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04096885` - The Inselspital Surgical Cohort Study
Terminated	`NCT03820648` - Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy	N/A
Completed	`NCT04067843` - Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study	N/A
Terminated	`NCT04042077` - Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections	Phase 3
Completed	`NCT05841576` - Anaesthetic Management Guided by COMET Measurements	N/A
Withdrawn	`NCT05338281` - NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT	N/A
Recruiting	`NCT03042091` - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery	Early Phase 1
Completed	`NCT01697748` - Prospective Study on Cesarean Wound Outcomes	N/A
Terminated	`NCT01789697` - Text Message Study	N/A
Recruiting	`NCT05966961` - Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Recruiting	`NCT05077592` - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections	Phase 4
Recruiting	`NCT05763602` - PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)	Phase 4
Recruiting	`NCT05502380` - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery	Phase 3
Recruiting	`NCT03221023` - Intrawound Vancomycin Prophylaxis for Neural Stimulator	Phase 2/Phase 3
Completed	`NCT03257202` - Topical Treatment and Prevalence of P. Acnes	Phase 2
Completed	`NCT06154720` - Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
Not yet recruiting	`NCT06465901` - A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI	N/A
Not yet recruiting	`NCT04820075` - Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery	N/A
Recruiting	`NCT03561376` - Zinc Oxide Versus Petrolatum Following Skin Surgery	Early Phase 1
Not yet recruiting	`NCT04496180` - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.