Efficacy of ActiveMatrix on Spinal SSI Rate

Launched by BAYLOR COLLEGE OF MEDICINE · Mar 17, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how effective a treatment called ActiveMatrix is in reducing the rate of infections at the surgical site after spinal surgery. The study is focused on patients who have been diagnosed with specific spinal conditions that require surgery, such as spinal stenosis, which can cause pain and discomfort in the lower back. The trial has not started recruiting participants yet, but it aims to include adults aged 18 to 100 who are willing to follow the study guidelines and provide informed consent.

To be eligible for this trial, participants must be diagnosed with spinal issues that require decompression or fusion surgery and should not have any allergies to the treatment being tested. The study will not include individuals involved in legal matters related to health, those with a known history of allergies to certain medical materials, or pregnant or breastfeeding women. If you decide to participate, you can expect to take part in a structured study that aims to improve surgical outcomes for spinal surgeries, helping to ensure a safer experience for future patients.

Gender

ALL

Eligibility 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.