MedTrace Logo

Efficacy of ActiveMatrix on Spinal SSI Rate

NCT05297513 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2022-04-07

No results posted yet for this study

Summary

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

Conditions

  • Spinal Stenosis Lumbar
  • Surgical Site Infection
  • Back 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.

Sponsors & Collaborators

  • Skye Biologics Holdings, LLC

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2025-07-31
Completion
2026-07-31
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05297513 on ClinicalTrials.gov