Hardware Preservation in Management of Infected Non United or Delayed United Fractures of Long or Short Bones by Debridement and Local Calcium Sulfate Loaded by Antibiotics

Sohag University

Status: Enrolling

Conditions: Infected Non Union and Delayed Union in Fractures of Both Long and Short Bones

Treatments: Procedure: local debridement and local calcium sulfate loaded by antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT05231148

soh-med-22-01-01

Details and patient eligibility

About

• Diagnosis of infection based on elevated serum markers of infection (ESR, CRP), discharging sinus, preoperative radiographs suggestive of bone infection and radiological findings . [6]
• infected nonunion mean the bone has previous fracture , the bone not healed may be one of the reasons it didn't heal because there is sub-acute infection , there is low grade colonization into the bone or around the wound preventing the bone from healing , it different from infected fracture which occur fairly acutely. [6, 7]
• Infected nonunion treated with systemic antibiotics alone, without using local antibiotic delivery systems associated with higher recurrence and reoperation rates. [7]
• This led to the development and use of medical-grade calcium sulfate (CS), CS facilitates osseous healing in an osteoconductive fashion by filling the bone void and preventing fibrous tissue

Enrollment: 10 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient at any age and of any sex with infected non united fracture of long or short bones

Exclusion criteria

• Presence of previous vascular injury or pathological fracture
• Refusal to participate
• Inability to provide informed consent
• Allergy or sensitivity to vancomycin or tobramycin
• Patient with impaired renal function
• Patient with hypercalcemia

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

infected non united fractures

Other group

Description:

patient of any age and any sex with infected non united fractures of long or short bones

Treatment:

Procedure: local debridement and local calcium sulfate loaded by antibiotics