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NCT04825522

The Effect of Intrawound Vancomycin Powder in Spine Surgery

Recruiting now Phase 4 Last updated 23 April 2024
What this trial tests

Phase 4 trial testing Vancomycin in Spine Disease in 1,643 participants. Currently enrolling.

Timeline
27 March 2022
Primary endpoint
1 December 2028
1 December 2028

Quick facts

Lead sponsorWindsor-Essex Compassionate Care Community
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment1,643
Start date27 March 2022
Primary completion1 December 2028
Estimated completion1 December 2028
Sites2 locations across Canada, Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Windsor-Essex Compassionate Care Community

Who can join

18 and older, any sex, with Spine Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Problem: Postoperative wound infection following various spinal surgeries is a serious complication. The incidence of post-surgical wounds in spine surgery is high, and various researchers have reported different infection rates. In addition, increased healthcare costs, prolonged lengths of stay in hospital, and reduced quality of life as a result of surgical site infections (SSI) are also major concerns. Several methods for avoiding SSI, such as betadine irrigation, vacuum-assisted closure, and intra-wound vancomycin powder, have been used to reduce the rate of wound infection in spine surgery. Use of local vancomycin has been popular because of its protective effects and lower cost. According to some reports, prophylactic administration of intra-wound vancomycin powder before wound closure is an effective method for decreasing postoperative wound infection rates; however, other studies have revealed a non-significant effect of intra-wound vancomycin use for decreasing the postsurgical wound infection rate. Solution: Therefore, the investigators will prospectively randomize all various types of spinal surgeries to patients who will receive intrawound vancomycin powder and control group who will not receive the powder and to see it's effect in reducing the post-surgical infection.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Vancomycin

Trials testing the same drug.

Other recruiting trials for Spine Disease

Currently open trials in the same condition.

Other Windsor-Essex Compassionate Care Community trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04825522.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing