Overview
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.
Description
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.
Eligibility
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