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Completed
NCT07866157
Efficacy of Intrawound Vancomycin in Spine Surgery
Conditions: Surgical Site Infection (SSI), Spine Diseases
Sex: All
Ages: 18 Years – 78 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 416
Sponsor: Ain Shams University
Location: Ain Shams University Hospitals. Cairo
Summary
This prospective, quasi-randomized, comparative study evaluated the efficacy of intrawound vancomycin powder (2 g) in preventing surgical site infections (SSI) following spine surgeries. The study included 416 patients who were allocated using alternating monthly time-clusters (25 months) to receive either standard care with topical vancomycin or standard care alone (control). The primary endpoint, the incidence of 90-day SSI, was evaluated by a blinded assessor to minimize bias.
Eligibility Criteria
Inclusion CriterInclusion Criteria:
* Adult patients undergoing elective open posterior instrumented spine surgery.
* Patients willing to participate and provide informed consent.
Exclusion Criteria:
* Presence of active systemic infection or local infection at the surgical site prior to surgery.
* Known allergy or hypersensitivity to vancomycin.
* Patients undergoing minimally invasive spine surgery (MISS) without formal open exposure.
* Previous history of surgical site infection in the spine.
Source: ClinicalTrials.gov (NCT07866157). StuddyBuddy aggregates publicly available trial information.