Efficacy of ActiveMatrix on Spinal SSI Rate

Phase 4

Not yet recruiting

• Conditions: Spinal Stenosis Lumbar; Back Pain Lower Back Chronic; Surgical Site Infection
• Interventions: Drug: ActiveMatrix

• Registration Number: NCT05297513
• Lead Sponsor: Baylor College of Medicine

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 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).

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-04-07
• Study Start: 2022-07
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ≥ 18 years of age to 100 years of age
4. Have a clinical diagnosis of thoracic and or lumbosacral spinal disease indicated for decompression and/or fusion
5. Have no contraindications or allergies to the treatment administered

Exclusion Criteria

1. Subject is involved with a worker's compensation, personal injury, or other legal matters related to their health
2. Subject does not provide full consent
3. Known history of allergy to allografts
4. Pregnancy or lactation
5. Minimally invasive spinal surgery
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment, plus ActiveMatrix	ActiveMatrix	-

Primary Outcome Measures

Name	Time	Method
90-day surgical site infection	90 days

Secondary Outcome Measures

Name	Time	Method
Fascial defects at 3-6 months for fusion cases	6 months
Improvement in back and leg pain	6 months	Oswestry Low Back Disability Questionnaire/Index (0-100, higher scores indicate greater disability)