New gel aims to reduce painful scarring after back surgery
NCT ID NCT06369233
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tests a new gel, MegaShield-SP, to see if it prevents scar tissue after spine surgery better than an existing gel. About 80 adults aged 20-70 with a herniated disc or spinal stenosis will receive one of the two gels during surgery. Researchers will measure scar formation on MRI and track pain and disability over time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2024
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Herniation, disc are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Bundang Seoul National University Hospital
Seongnam-si, 13620, South Korea
-
Eunpyeong ST. Mary's Hospital
Seoul, 03312, South Korea
-
Gangnam Severance Hospital
Seoul, 06273, South Korea
-
Severance Hospital
Seoul, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can contrast spread predict which sciatica injection works?
- Can ultrasound dye reveal spinal cord damage Mid-Surgery?
- Teaching the brain about pain before surgery may ease recovery
- Back therapy may give lungs a boost: trial tests breathing benefits
- Could a nasal spray shield aging brains from Post-Surgery confusion?
- Can a One-Day mindset workshop stop chronic pain after back surgery?