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

L&C Bio

Status: Enrolling

Conditions: Herniation, Disc

Treatments: Device: Guardix-SP Plus; Device: MegaShield®-SP

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06369233

LNC-MS-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

MegaShield®-SP

Experimental group

Description:

The study group is applied with MegaShield®-SP after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 week to conduct examinations and assess Questionnaires.

Treatment:

Device: MegaShield®-SP

Guardix-SP Plus

Active Comparator group

Description:

The study group is applied with Guardix-SP after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 week to conduct examinations and assess Questionnaires.

Treatment:

Device: Guardix-SP Plus