A Phase 4 interventional study of ActiveMatrix in Spinal Stenosis Lumbar, Surgical Site Infection and Back Pain Lower Back Chronic, sponsored by Baylor College of Medicine. Not yet recruiting. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Baylor College of Medicine · Phase 4, Interventional, and Prevention
This clinical trial seeks to provide high level of evidence on the efficacy of ActiveMatrix primarily on spinal surgical site infection rate.
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 rate in patients with comorbidities including obesity, smoking history, diabetes, steroid use, older age, and higher modified frailty index.2 Patients of Veterans Affairs (VA) medical centers have higher number of comorbidities than non-VA patients, and are therefore at higher risk for postoperative spinal SSI and complications.3,4 Spinal SSI has been reported to be anywhere from \<1% in decompressions to >10% after instrumented fusion.5 Anecdotal evidence has suggested SSI to be as high as 20% among our population. As spine surgeons for the largest VA in the country, our team sought a product that could reduce the rate of spinal SSI, and ideally result in improved patient outcomes, in our at-risk patient population.
Skye Biologics offers placental tissue-based matrices in the form of both flowable and solid mediums. The flowable matrix has been shown in-vitro to contain significant amounts of collagen and growth factors, as well as molecules known to modulate immune response. The results of this have been in-vitro inhibition of methicillin resistant Staphylococcus aureus (MRSA) and Staphylococcus saprophyticus proliferation, increase in migration of adipose-derived stem cells (ASCs), adherence to the ASCs in cultures.6 In translation of these results clinical application has been well received, with various subspecialties including ENT and orthopedics using the products. Based on both the positive in vitro and in vivo results, out team began using the flowable product with good initial subjective results, including improved wound healing and excellent patient satisfaction. The true clinical efficacy remains to be assessed, however. Our team sought to provide level 1 evidence on this product in thoracolumbosacaral posterior spinal decompression and/or fusion in our at-risk population via a single-blinded randomized control trial at high-volume institution (s).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 275 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
There is no intended distribution or restriction of subjects by racial and ethnic origin. No vulnerable subjects are included in this protocol.
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.
90-day surgical site infection
Time frame: 90 days
Fascial defects at 3-6 months for fusion cases
Time frame: 6 months
Improvement in back and leg pain
Oswestry Low Back Disability Questionnaire/Index (0-100, higher scores indicate greater disability)
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine