Incidence of Fracture-Related Infection Among Adult Trauma Patients Undergoing Operative Fracture Fixation A Prospective Cohort Study at the Orthopaedic and Trauma Surgery Unit, Assiut University Hospital

NCT07853404 | Not Yet Recruiting DMC

• 1 other identifier: Incidence Fracture +Infection
• Study Type: observational
• Target: 375
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fracture-related infection (FRI) is an infection occurring after operative or non-operative management of a fracture, and it represents one of the most serious complications encountered in orthopaedic trauma surgery. In 2018, an international expert group convened by the AO Foundation and the European Bone and Joint Infection Society (EBJIS) published a consensus definition for FRI, establishing standardized confirmatory and suggestive diagnostic criteria to overcome the historical absence of a uniform case definition, which had previously hampered both clinical practice and comparability of research in this field.

• FRI can complicate both open and closed fractures treated by internal or external fixation. Its clinical spectrum ranges from early post-operative wound infection to chronic, recalcitrant post traumatic osteomyelitis, fracture non-union and, in severe cases, amputation of the affected limb.
• The burden of FRI is multidimensional and falls on the patient, the treating surgical team, and the wider community Reported incidence of FRI varies widely according to fracture type, anatomical site and host/injury-severity factors. Pooled estimates from the literature suggest an overall incidence of approximately 0.4-16% across all operatively treated fractures: closed fractures carry a substantially lower risk (approximately 1-2%) than open fractures, in which incidence commonly exceeds 15% and rises further with increasing severity of soft-tissue and bony injury. A large multicentre cohort from India applying prospective follow-up reported an overall infection incidence of 2.9% (1.6% in closed and 8.0% in open tibial fractures) . Risk is further modulated by patient-related factors (diabetes mellitus, smoking, obesity, immunosuppression), injury related factors (high-energy mechanism, soft-tissue compromise, contamination) and treatment related factors (timing of antibiotic prophylaxis and surgical debridement, type of fixation, duration of surgery)

Conditions

Fracture Related Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of fracture-related infection

  Incidence of fracture-related infection, diagnosed using the international FRI consensus criteria in Trauma unit assiut university hospital, expressed as a proportion (%) with 95% confidence interval - overall, and stratified by fracture type (open/closed) and Gustilo-Anderson grade for open fractures.

  within 12 months of the index operative fixation

Study Arms (1)

study group

Adults aged ≥18 years with Open or closed fracture of the appendicular skeleton (long bones, hand, foot, pelvis/acetabulum) requiring operative fixation in the trauma theatre of the unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient with Open or closed fracture of the appendicular skeleton (long bones, hand, foot, pelvis/acetabulum) requiring operative fixation in the trauma theatre of the unit

You may qualify if:

• Open or closed fracture of the appendicular skeleton (long bones, hand, foot, pelvis/acetabulum) requiring operative fixation in the trauma theatre of the unit
• Surgery performed at the Orthopaedic and Trauma Surgery Unit, Assiut University Hospital, during the study period
• Patient (or legal guardian, where temporary incapacity precludes immediate consent) willing and able to provide informed consent and to participate in scheduled follow-up

You may not qualify if:

• Pathological fractures secondary to malignancy or to metabolic bone disease other than simple osteoporosis (different infection biology and risk profile)
• Periprosthetic fractures, or fractures around a pre-existing implant/prosthesis (risk of misclassification with periprosthetic joint infection, which has its own distinct consensus definition)
• Fractures of the skull, and of the cervical, thoracic or lumbar spine (excluded by precedent in the FRI validation literature, given differing anatomy, infection biology and applicability of the consensus criteria)
• Patients presenting with infection already established at the fracture site prior to, or at the time of, the index surgery at our unit (e.g., late transfer from another facility with a pre existing diagnosis of infection) - excluded to preserve ascertainment of incident (new) rather than prevalent infection
• Fractures managed non-operatively (conservatively)
• Death within 48 hours of surgery from a cause unrelated to infection, precluding any meaningful infection follow-up
• Non-resident patients (e.g., without a reliable local follow-up address) in whom completion of the minimum follow-up period cannot reasonably be assured

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09