Periimplant Infection Clinical Trial
Official title:
Sonication of Syndesmotic Screws
Peri-implant infections are severe complications after internal fracture fixation surgery.
Detection of causative agents of orthopedic implant-associated infections (OIAI) is
demanding. Several authors reported increased identification rates of bacterial prevalence
using different sonication procedures compared to standard tissue cultures samples,
especially for low grade infections.
On the author hand, contamination of implants without clinical signs of infection is reported
in up to 30% during implant removals after uneventful fracture healing. The raised general
questions are: 1.) Is a positive microbiological finding the result of contamination during
the index surgery or during implant removal? 2.) Does contaminated implants without clinical
or serological signs of infection have a pathological value?
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with syndesmotic screw removal after open reduction and internal fixation with plates and additional syndesmotic screw of ankle fractures (Weber B or C) in our department. Exclusion Criteria: - Patients with immunosuppressive diseases or therapies, - Pregnant women - Patients with pre-operations on the same ankle-joint - Patients with initial surgery for fracture fixation in other hospitals. |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Trauma-, Hand- and Reconstructive Surgery | Jena | Thüringen |
Lead Sponsor | Collaborator |
---|---|
Jena University Hospital |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection rate of syndesmotic screw contamination using a sonication procedure compared to standard wound swabs | six weeks | ||
Secondary | Clinical manifestation of infections by contaminated fracture fixation implants | six months |