Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison … (NCT06369233) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery
South Korea80 participantsStarted 2024-04-01
Plain-language summary
This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied.
Who can participate
Age range20 Years – 70 Years
SexALL
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Inclusion Criteria:
* Patients aged 20 to 70 years.
* Patient diagnosed with single-level lumbar disc herniation and scheduled to perform Lumbar discectomy, or patients diagnosed with single-level spinal stenosis and scheduled to perform laminectomy.
* Patients who voluntarily decide to participate in the study and voluntarily agree in writing to the informed consent form.
Exclusion Criteria:
* Patients diagnosed with multi-level lumbar disc herniation or lumbar disectomy ,far lateral lumbar disc herniation(FLLDH).
* Patient diagnosed with spinal cord disease
* Patient who needs spinal fusion
* Patient who has previous experience in spinal surgery
* Patient diagnosed with a serious liver or kidney disease
* Patients with lymph fluid or blood clotting disorder or taking antithrombotic or antiplatelet agents
* Patients with uncontrolled diabetes that may affect surgery or postoperative progress according to the investigator's judgment,
* Patients with immunocompromised or autoimmune diseases such as rheumatoid arthritis or systemic erythematosus lupus, and severe systemic immune disease
* Patients with infectious diseases or healing disorders that can interfere with the normal healing process after surgery
* Patients who received steroid epidural injections within 2 weeks from the date of screening or who took oral steroids within 24 hours
* Patients who participated in other clinical trials within 30 days from the date of screening
* Patients who are unable to take MRI scan…