Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 4

Conditions: Open Tibia Fracture; Tibial Fractures; Osteomyelitis Tibia

Treatments: Drug: Antibiotic coated intramedullary Nail; Other: Standard Intramedullary Nail

Study type: Interventional

Funder types: Other

Identifiers

NCT05421741

01012022

IRB00086285

40010222 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 484 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years or older
• Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail

Exclusion criteria

• Less than 18 years of age
• Allergy to vancomycin or gentamicin
• Unable to speak English or Spanish
• Pregnant and lactating women
• Prisoner
• Unable to follow up for 12 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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484 participants in 2 patient groups

Intramedullary Nail

Active Comparator group

Description:

Traditional standard of care intramedullary (IM) nail

Treatment:

Other: Standard Intramedullary Nail

Antibiotic Coated Intramedullary Nail

Active Comparator group

Description:

Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.

Treatment:

Drug: Antibiotic coated intramedullary Nail