Status:
NOT_YET_RECRUITING
Efficacy of ActiveMatrix on Spinal SSI Rate
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Skye Biologics Holdings, LLC
Conditions:
Spinal Stenosis Lumbar
Surgical Site Infection
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
This clinical trial seeks to provide high level of evidence on the efficacy of ActiveMatrix primarily on spinal surgical site infection rate.
Detailed Description
Postoperative spinal surgical site infections (SSI) have a significant effect on patient morbidity and mortality.1 Spinal SSI as well as other complications including pseudoarthrosis occur at a higher...
Eligibility Criteria
Inclusion
- 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
- Have no contraindications or allergies to the treatment administered
Exclusion
- 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
- Minimally invasive spinal surgery
- Non-fusion instrumented cases requiring drains
- There is no intended distribution or restriction of subjects by racial and ethnic origin. No vulnerable subjects are included in this protocol.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT05297513
Start Date
July 1 2022
End Date
July 1 2026
Last Update
April 7 2022
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