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NCT07201987
Intraoperative Placement of Vancomycin-impregnated Calcium Sulfate Beads Conjugated With Analgesics to Improve Spine Surgery Outcomes
Phase 2 trial testing Vancomycin (local, via calcium sulfate beads) in Spine Surgery in 100 participants. Not yet recruiting.
1 January 2028
Quick facts
| Lead sponsor | Ganesh M. Shankar |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 January 2027 |
| Primary completion | 1 January 2028 |
| Estimated completion | 1 January 2028 |
Drugs / interventions tested
- Vancomycin (local, via calcium sulfate beads) — full drug profile →
- Morphine (local, via calcium sulfate beads) — full drug profile →
- Bupivacaine (local, via calcium sulfate beads) — full drug profile →
Conditions studied
- Spine Surgery — all drugs for Spine Surgery →
- Postoperative Pain Management — all drugs for Postoperative Pain Management →
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.
Verify or expand the search:
- PubMed search for NCT07201987
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Related trials
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- NCT06785350 — Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07201987 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ganesh M. Shankar
- Last refreshed: 16 April 2026
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