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Antibiotic-Loaded Cement Beads for Reducing Infection in Open Lower-Extremity Fractures (Gustilo-Anderson IIIA): A Prospective Cohort Study with Historical Controls

Antibiotic-Loaded Cement Beads for Reducing Infection in Open Lower-Extremity Fractures (Gustilo-Anderson IIIA): A Prospective Cohort Study with Historical Controls

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260624001
Enrollment
46
Registered
2026-06-24
Start date
2025-03-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults aged 18-65 years with open tibial or femoral Gustilo-Anderson IIIA fractures who reached the hospital within 24 hours were eligible Open fracture Gustilo-Anderson IIIA antibiotic cement beads surgical site infection fracture-related infection tibia femur PMMA vancomycin gentamicin

Interventions

In the index group, after meticulous debridement, povidone-iodine skin preparation, and low-pressure pulsed lavage with at least 3 L of normal saline, antibiotic cement beads were prepared by mixing 2
Experimental Other
Antibiotic-Loaded Cement Beads

Sponsors

Srinakharinwirot University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Eligibility criteria for the index group were 1. Gustilo-Anderson type IIIA open fracture of the tibia or femur diagnosed by an attending orthopaedic surgeon 2. age 18 to 65 years (skeletally mature) 3. ability to attend follow-up for 6 months 4. hospital arrival within 24 hours of injury. Historical controls were identified from electronic medical records of patients who met identical inclusion criteria during the period preceding routine bead use, and who had complete demographic data, operative records, and follow-up radiographs at 1, 3, and 6 months.

Exclusion criteria

Exclusion criteria: Exclusion criteria for both groups were 1. known allergy to cephalosporins, aminoglycosides, penicillins, or PMMA constituents 2. previous surgery or infection at the same site 3.immunocompromise (uncontrolled diabetes mellitus, AIDS, end-stage renal disease) 4. cognitive impairment that precluded follow-up 5. subsequent amputation 6. development of multidrug-resistant infection prior to bead implantation

Design outcomes

Primary

MeasureTime frame
Infection rate 6 months after the intervention Incidence of infection (present of any sign based on CDC National Healthcare Safety Network (NHSN) surgical-site-infection criteria and the Govaert fracture-related-infection (FRI) consensus)

Secondary

MeasureTime frame
Union score 1,3, and 6 months after the intervention Modified Radiographic Union Score for Tibial Fractures

Countries

Thailand

Contacts

Public ContactWittawat Boonyanuwat

Faculty of Medicine, Srinakharinwirot University

wittawatb@g.swu.ac.th0802445777

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026