Infection Prevention During Spine Surgery Study
The purpose of this study is to learn whether vaccination with SA4Ag, given 10 to 60 days before surgery, can help prevent infections after surgery caused by staph. To obtain this information, we will closely monitor you for signs of infection for 6 months after your surgery.
In order to participate you must meet the following criteria:
- Sign and date the informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
- Be aged 18 to <86 years at the time of enrollment.
- Be scheduled to undergo an elective posterior instrumented lumbar spinal fusion procedure (as defined in Section 3.3) 10 to 60 days after study vaccination.
- Be available for the entire duration of the study, and be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including completion of the electronic diary (e-diary) for 10 days after study vaccination.
- Be able to be contacted by telephone during study participation.
You will be excluded from the study if any of the following criteria apply to you:
- Have planned spinal fusion procedure requiring separate operations performed on separate days (ie, staged procedure).
- Have surgical indication of malignancy, infection, or acute or emergency trauma.
- Have a history of major surgery (specifically, an open procedure that enters a body cavity, organ, or joint space) within 3 months prior to enrollment, or anticipated major surgery other than the index surgical procedure between study enrollment and completion of study participation.
- Have a history of any spinal surgery performed within 6 months prior to study enrollment.
This is a partial list of inclusion and exclusion criteria. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message. Additional evaluation for study eligibility will be done by your study doctor.