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The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study

NCT06034041 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-09-14

No results posted yet for this study

Summary

The goal of this clinical trial is to compare efficacy and safety of Mediclore as anti-adhesion agent in patient who undergo endoscopic lumbar discectomy. The main question\[s\] it aims to answer are:

* efficacy (patient-reported outcomes, epidural fibrosis)
* safety (complications) Participants will received Mediclore at surgical site after finish the operation in experimental group and normal saline in control group.

Researchers will compare to see if experimental group have better patient-reported outcomes (PROs) after surgery with no different in complications rate.

Conditions

  • Lumbar Disc Disease
  • Epidural Fibrosis
  • Failed Back Surgery Syndrome

Interventions

DRUG

Mediclore

After finish the operation, Mediclore group will be applied 1.5 CC of Mediclore at the surgical site. Mediclore is a Poloxamer-based thermosensitive anti-adhesive agent which is in a liquid solution and transform to a gel-state after being in a body temperature.

DRUG

Normal Saline

After finish the operation, Control group will be applied 1.5 CC of normal saline at the surgical site.

Sponsors & Collaborators

  • King Chulalongkorn Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2024-03-31
Completion
2024-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06034041 on ClinicalTrials.gov