Clinical Trial

Dose-Response Association Between Cerclage Wire Number and Infection Risk

Study acronym: C-INFECT
Completed
View on ClinicalTrials.gov →
Summary
The purpose of this dual-center retrospective study is to investigate the relationship between the number of metallic cerclage wires used in femoral fracture surgery and the risk of developing deep infections. Cerclage wiring is a common technique used to hold bone fragments together during the fixation of complex thigh bone (femur) or hip replacement-related (periprosthetic) fractures. While these wires provide mechanical stability, adding foreign material to the body may increase the risk of bacterial colonization and biofilm formation. Researchers reviewed the medical records of 148 patients treated between 2015 and 2025 at two Level I trauma centers. Patients were divided into three groups based on the "implant burden": those with 1 wire, 2 wires, or 3 or more wires. The study evaluated two main complications: Persistent wound drainage (PWD): Continued fluid leakage from the surgical site for more than 5 days. Deep infection: Serious infections involving deep tissues or the bone that require additional surgery or long-term antibiotics. The results showed a significant "dose-dependent" link, meaning that as the number of wires increased, the risk of drainage and infection also rose significantly, regardless of the length of the surgery. The study suggests that surgeons should use the minimum number of wires necessary to maintain stability to reduce these biological risks.
Trial Details
NCT Number NCT07434258
Lead Sponsor Istanbul University
Collaborators: Aksaray University Training and Research Hospital
Conditions Femur Fracture, Periprosthetic Fracture of Hip, Periprosthetic Fracture of the Femur, Surgical Site Infection (SSI), Biofilms, Postoperative Complications
Enrollment 148 participants
Start Date 2015-04-10
Primary Completion 2025-01-20 (estimated)
Study Completion 2025-03-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-25