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NOT YET RECRUITING
NCT05297513
PHASE4

Efficacy of ActiveMatrix on Spinal SSI Rate

Sponsor: Baylor College of Medicine

View on ClinicalTrials.gov

Summary

This clinical trial seeks to provide high level of evidence on the efficacy of ActiveMatrix primarily on spinal surgical site infection rate.

Official title: Efficacy of ActiveMatrix on Spinal Surgical Site Infection (SSI) Reduction: A Single-blinded Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

275

Start Date

2022-07

Completion Date

2026-07

Last Updated

2022-04-07

Healthy Volunteers

Yes

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.