Clinical trial NCT06369233: Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison with Guardix-SP Plus After Spine Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Herniation, Disc
Keywords: disc herniation
laminectomy
anti-adhesion
disc resection
MegaShield
MegaShield-SP
Lead sponsor: L&C Bio
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 criteria: 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

Primary outcomes:
measure: MRI scar score
timeFrame: At 12 weeks after surgery
Secondary outcomes:
measure: Oswestry Disability Index(ODI) score
timeFrame: Before surgery, At 2, 12 weeks after surgery
measure: Visual Analog Scale(VAS) Back & Leg Pain Score
timeFrame: Before surgery, At 2, 12 weeks after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eunpyeong ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Bundang Seoul National University Hospital
Study officials:
affiliation: Yonsei University College of Medicine, Severance Hospital
name: Siyoung Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Yonsei University College of Medicine Gangnam severance Hospital
name: Jiwon Kwon
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Hojung Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Eunpyeong St. Mary's Hospital
name: HyungYul Park
role: PRINCIPAL_INVESTIGATOR
References: