Efficacy of ActiveMatrix on Spinal SSI Rate
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
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
Treatments tested in this trial
- ActiveMatrix
Treatment groups
275 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Baylor College of Medicine
Lead sponsor
Skye Biologics Holdings, LLC
Collaborator
Source ClinicalTrials.gov