Efficacy of ActiveMatrix on Spinal SSI Rate
Unknown statusPhase 4NCT05297513
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This clinical trial seeks to provide high level of evidence on the efficacy of ActiveMatrix primarily on spinal surgical site infection rate.
Study details
- Official title
- Efficacy of ActiveMatrix on Spinal Surgical Site Infection (SSI) Reduction: A Single-blinded Randomized Controlled Trial
- Conditions
- Spinal Stenosis Lumbar
- Surgical Site Infection
- Back Pain Lower Back Chronic
- Interventions
- Drug: ActiveMatrix
- Sponsor
- Baylor College of Medicine
- Collaborators
- Skye Biologics Holdings, LLC
- Start date
- 2022-07
- Primary completion
- 2025-07
- Sex
- All
- Age range
- from 18 Years to 100 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05297513