Efficacy of ActiveMatrix on Spinal SSI Rate

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

July 31, 2022

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2026

Conditions
Spinal Stenosis LumbarSurgical Site InfectionBack Pain Lower Back Chronic
Interventions
DRUG

ActiveMatrix

All patients will receive weight based prophylactic antibiotics i.e. Ancef, vancomycin, or clindamycin. Drains will be used in fusion cases only. Intrawound vancomycin will be used for all instrumented cases.No negative pressure devices will be used. Anatomic layers will be closed in similar, standard fashion for all cases. For those randomized to the treatment group, the ActiveMatrix product will be administered on top of the dura mater and again on the closed fascia. Those in the control group, will forgo this step.

All Listed Sponsors
collaborator

Skye Biologics Holdings, LLC

INDUSTRY

lead

Baylor College of Medicine

OTHER

NCT05297513 - Efficacy of ActiveMatrix on Spinal SSI Rate | Biotech Hunter | Biotech Hunter