Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. Infection in an active duty military population increases disability and decreases the likelihood of returning to duty. In addition, infection is one of the main factors associated with rehospitalization. Further, deep infections have not only resulted in increased disability after injury, infection is implicated as one of the main factors in late amputation. Among service members, only 20-25% with a severe open tibia fracture are able to return to active duty. Novel techniques for reducing infection are needed. The proposed study addresses the focus area of fracture-related infections, specifically the prevention of infection. 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. 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. The target population for the proposed study is patients with severe open tibia fractures (Type II or Type III) who require definitive fixation with intramedullary nail recruited from one of the participating sites during the index hospitalization. One group will be treated prophylactically using an antibiotic coated intramedullary nail at time of definitive fixation (1CN), while the second group will be treated with traditional standard of care intramedullary nail without antibiotic-coating (SN). Participant will be followed for 12 months (data capture including patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05421741
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact	Rachel Seymour, PhD
Phone	7043552000
Email	Rachel.Seymour@atriumhealth.org
Status	Recruiting
Phase	Phase 4
Start date	May 15, 2023
Completion date	December 2027

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05459038` - Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.	N/A
Terminated	`NCT02845245` - Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques	N/A
Completed	`NCT02456194` - Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial	N/A
Terminated	`NCT00667849` - Trial to Evaluate UltraSound in the Treatment of Tibial Fractures	N/A
Completed	`NCT01132508` - Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures	N/A
Completed	`NCT00512434` - Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture	N/A
Completed	`NCT00161616` - Study Evaluating InductOs in Diaphyseal Tibia Fractures	Phase 4
Terminated	`NCT03881241` - Safety Study of Treatment of Leg Fractures
Completed	`NCT02750072` - INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia	N/A
Completed	`NCT04015167` - A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
Completed	`NCT05613257` - Distal Targeter vs Free-hand	N/A
Completed	`NCT03388879` - Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures	N/A
Completed	`NCT02491047` - Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures	N/A
Completed	`NCT01797640` - Intramedullary Nailing of Tibia Fractures	N/A
Recruiting	`NCT03232216` - Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?	N/A
Withdrawn	`NCT03826784` - Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures	Phase 3
Terminated	`NCT00253981` - Light Therapy in the Treatment of Leg Pain	N/A
Completed	`NCT05303389` - Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures	N/A
Recruiting	`NCT05272631` - Depuy Synthes Lower Extremity Shaft Nail Registry
Completed	`NCT03540719` - Surgical Management of Posterior Tibial Plateau Fractures

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.