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Spinal Stenosis LumbarPhase 4NCT05297513

Efficacy of ActiveMatrix on Spinal SSI Rate

A Phase 4 study testing ActiveMatrix in people with Spinal Stenosis Lumbar and Surgical Site Infection, run by Baylor College of Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
What is being tested?
ActiveMatrix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
No sites listed yet
Study dates
Jul 2022to Jul 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: Efficacy of ActiveMatrix on Spinal Surgical Site Infection (SSI) Reduction: A Single-blinded Randomized Controlled Trial

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

Read the 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 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).

Being tested
ActiveMatrix
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ActiveMatrixDrug

    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.

Study groups in NCT05297513
Study groupRoleWhat they receive
Standard treatment, no interventionNo interventionNot described
Standard treatment, plus ActiveMatrixExperimentalNot described
Receives: Drug: ActiveMatrix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 90-day surgical site infection

    Measured: 90 days

Secondary outcomes (2)

  1. Fascial defects at 3-6 months for fusion cases

    Measured: 6 months

  2. Improvement in back and leg pain

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study startJul 2022 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
275 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297513
Sponsor's protocol ID
H-51093
Status last verified
Mar 2022
First submitted
17 Mar 2022
Last updated
7 Apr 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Casper DS, Zmistowski B, Hollern DA, Hilibrand AS, Vaccaro AR, Schroeder GD, Kepler CK. The Effect of Postoperative Spinal Infections on Patient Mortality. Spine (Phila Pa 1976). 2018 Feb 1;43(3):223-227. doi: 10.1097/BRS.0000000000002277.

    PubMed 28604484

  • Badiee RK, Mayer R, Pennicooke B, Chou D, Mummaneni PV, Tan LA. Complications following posterior cervical decompression and fusion: a review of incidence, risk factors, and prevention strategies. J Spine Surg. 2020 Mar;6(1):323-333. doi: 10.21037/jss.2019.11.01.

    PubMed 32309669

  • Melzer AC, Pinsker EA, Clothier B, Noorbaloochi S, Burgess DJ, Danan ER, Fu SS. Validating the use of veterans affairs tobacco health factors for assessing change in smoking status: accuracy, availability, and approach. BMC Med Res Methodol. 2018 May 11;18(1):39. doi: 10.1186/s12874-018-0501-2.

    PubMed 29751746

  • Agha Z, Lofgren RP, VanRuiswyk JV, Layde PM. Are patients at Veterans Affairs medical centers sicker? A comparative analysis of health status and medical resource use. Arch Intern Med. 2000 Nov 27;160(21):3252-7. doi: 10.1001/archinte.160.21.3252.

    PubMed 11088086

  • O'Toole JE, Eichholz KM, Fessler RG. Surgical site infection rates after minimally invasive spinal surgery. J Neurosurg Spine. 2009 Oct;11(4):471-6. doi: 10.3171/2009.5.SPINE08633.

    PubMed 19929344

  • Irvin J, Danchik C, Rall J, Babcock A, Pine M, Barnaby D, Pathakamuri J, Kuebler D. Bioactivity and composition of a preserved connective tissue matrix derived from human placental tissue. J Biomed Mater Res B Appl Biomater. 2018 Nov;106(8):2731-2740. doi: 10.1002/jbm.b.34054. Epub 2018 Feb 13.

    PubMed 29437272

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ActiveMatrix in people with Spinal Stenosis Lumbar and Surgical Site Infection, run by Baylor College of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

90-day surgical site infection (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297513, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.

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