A Phase 3 interventional study of vancomycin and Standard surgical closure in Surgical Site Infection (SSI) and Spine Diseases, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 15 Years to 78 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Ain Shams University · Phase 3, Interventional, and Prevention
"This multicenter, prospective, time-cluster randomized controlled trial with blinded endpoint assessment (PROBE design) 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 blinded clinical assessors to minimize bias."
This study was designed to overcome the logistical challenges of individual randomization within operating rooms by utilizing a time-cluster allocation approach. Over a 25-month period, alternating months were designated as either intervention or control clusters. The vancomycin group included 207 patients, and the standard care control group included 209 patients. Baseline demographic and clinical characteristics, including age, sex, smoking status, and diabetes mellitus, were statistically balanced between the two cohorts.
Patients in the active cluster received 2 grams of vancomycin powder applied directly to the subfascial and deep layers prior to wound closure. Patients in the control cluster received standard surgical closure without topical antibiotics. All participants were followed for up to 90 days post-operatively.
To minimize detection bias in this open-label surgical intervention, a Prospective Randomized Open, Blinded End-point (PROBE) design was strictly enforced. All primary and secondary infection outcomes were independently evaluated and diagnosed by clinical assessors who were completely blinded to the patients' cluster allocation and treatment status.
687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.
This study's enrollment of 416 is above the median of 200 across 526 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients operated on during the intervention time-clusters received 2 grams of intrawound vancomycin powder applied topically to the deep and subfascial layers prior to wound closure.
Drug: vancomycin
Patients operated on during the control time-clusters received standard surgical site preparation and standard wound closure without the application of topical intrawound antibiotics.
Procedure: Standard surgical closure
Application of 2 grams of intrawound vancomycin powder topically to the deep and subfascial layers prior to wound closure.
Also known as: vancomycin 2 gram
Standard surgical site preparation and standard wound closure without the application of topical intrawound antibiotics.
INCIDENCE OF SURGICAL SITE INFECTION (SSI)
The primary outcome is the occurrence of any superficial, deep, or organ/space surgical site infection (SSI) following the index spine surgery. SSI is diagnosed and classified according to the standard criteria set by the Centers for Disease Control and Prevention (CDC).
Time frame: UP TO 90 DAYS
Depth of Surgical Site Infection (SSI)
Classification of the surgical site infection according to the depth of tissue involvement (superficial incisional, deep incisional, or organ/space), based on the standard Centers for Disease Control and Prevention (CDC) criteria.
Time frame: UP TO 90 DAYS
Microbiological Profile of Surgical Site Infections
Identification of the causative bacterial organisms in patients who develop a surgical site infection (SSI). This includes analyzing the incidence of specific pathogens (e.g., Gram-positive bacteria such as MRSA, and Gram-negative bacteria) isolated from deep wound cultures.
Time frame: Up to 90 days post-operatively
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2023 to primary completion in May 2026, 29 months.
Of 35 phase 3 interventional studies under Surgical Wound Infection, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 53. This study's 29 months is below that.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vancomycin