Efficacy of ActiveMatrix on Spinal SSI Rate

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Skye Biologics

Criteria

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.