Health TrialsbyHealthPanel

Efficacy of ActiveMatrix on Spinal SSI Rate

ConditionsSpinal Stenosis LumbarSurgical Site InfectionBack Pain Lower Back Chronic
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBaylor College of Medicine

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, ≥ 18 years of age to 100 years of age

Have a clinical diagnosis of thoracic and or lumbosacral spinal disease indicated for decompression and/or fusion

Disqualifiers

Subject is involved with a worker's compensation, personal injury, or other legal matters related to their health

Subject does not provide full consent

Known history of allergy to allografts

Pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • ActiveMatrix

    Drug

    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.

Treatment groups

275 Participants
are divided into 2 treatment groups
Group A: Standard treatment, no interventionNo intervention 0 interventions
Group B: Standard treatment, plus ActiveMatrixExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

90-day surgical site infection

Time frame
90 days

Secondary outcomes

1

Fascial defects at 3-6 months for fusion cases

Time frame
6 months
2

Improvement in back and leg pain

Oswestry Low Back Disability Questionnaire/Index (0-100, higher scores indicate greater disability)

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

Skye Biologics Holdings, LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: