Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery

Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery: A Multicenter, Randomized, Subjects-independent Evaluator Blinded, Active-control Comparative, Non-inferior, Prospective Confirmatory Clinical Study

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.

To evaluate preventing adhesion, the study group is compared with MegaShield®-SP or Guardix-SP Plus after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 weeks to conduct examinations and assess Questionnaires.

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 scans
• Pregnant or lactating women
• Patients who are not eligible for clinical trials according to the investigator's judgement
• Patients with a history of hypersensitivity to the main and other components of the investigational device
• Patients who are scheduled to receive myelogram or lumbar puncture within 24 hours from the application of the investigational device