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NCT07201987

Intraoperative Placement of Vancomycin-impregnated Calcium Sulfate Beads Conjugated With Analgesics to Improve Spine Surgery Outcomes

Not yet recruiting Phase 2 Last updated 16 April 2026
What this trial tests

Phase 2 trial testing Vancomycin (local, via calcium sulfate beads) in Spine Surgery in 100 participants. Not yet recruiting.

Timeline
1 January 2027
Primary endpoint
1 January 2028
1 January 2028

Quick facts

Lead sponsorGanesh M. Shankar
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment100
Start date1 January 2027
Primary completion1 January 2028
Estimated completion1 January 2028

Drugs / interventions tested

Conditions studied

Sponsor

Ganesh M. Shankar — full company profile →

Who can join

18 and older, any sex, with Spine Surgery or Postoperative Pain Management. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn if using calcium sulfate beads that contain vancomycin (an antibiotic) and pain-relieving medicines during spine surgery can improve recovery compared to standard care with intravenous (IV) morphine and local pain medicines. Researchers want to know if the sustained release formulation of morphine from these calcium sulfate beads affect: * Postoperative length of stay * Postoperative pain scores * Postoperative narcotic analgesic requirements All participants in this study will already be scheduled to have spine surgery as part of their regular medical care. During surgery, participants will be assigned to receive either intraoperative placement of calcium sulfate beads with vancomycin alone or vancomycin with morphine and bupivacaine. All patients will still have access to standard of care with IV and PO pain regimens. Participants will then be followed after surgery to measure their pain, recovery, and medication use. Participation is voluntary, and choosing not to join will not affect a person's medical care.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Spine Surgery

Currently open trials in the same condition.

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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/NCT07201987.

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