NCT06034041

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 2, 2023

Last Update Submit

September 12, 2023

Conditions

Lumbar Disc DiseaseEpidural FibrosisFailed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Score for Leg pain (VAS Leg)

    The VAS Leg consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('the worst pain in a lifetime'). The patient was asked to rate their current pain level by pointing the mark on the line.

    3 month after surgery

Secondary Outcomes (6)

  • Visual Analogue Score for Leg and Back pain (VAS Leg, Back)

    1, 3 and 6 month after surgery (for VAS Back) and 1 and 6 month after surgery (for VAS Leg)

  • Oswestry Disability Index (ODI)

    1, 3 and 6 month after surgery

  • EQ-5D-5L

    1, 3 and 6 month after surgery

  • Epidural Fibrosis

    3 month after surgery

  • Complication rate

    peri-operation, 1, 3 and 6 month after surgery

  • +1 more secondary outcomes

Study Arms (2)

Mediclore

EXPERIMENTAL

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: Mediclore

Control

PLACEBO COMPARATOR

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

Drug: Normal Saline

Interventions

MedicloreDRUG

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.

Mediclore
Normal SalineDRUG

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

Also known as: Control
Control

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lumbar disc herniated patients
  • Failed proper conservative treatment more than 6 months

You may not qualify if:

  • Previous history of lumbar spine surgery OR lumbar epidural steroid injection
  • Infection OR malignancy
  • Allergic to any given components
  • Lactation and pregnency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (23)

  • Atlas SJ, Keller RB, Chang Y, Deyo RA, Singer DE. Surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: five-year outcomes from the Maine Lumbar Spine Study. Spine (Phila Pa 1976). 2001 May 15;26(10):1179-87. doi: 10.1097/00007632-200105150-00017.

    PMID: 11413434BACKGROUND

  • Hansson E, Hansson T. The cost-utility of lumbar disc herniation surgery. Eur Spine J. 2007 Mar;16(3):329-37. doi: 10.1007/s00586-006-0131-y. Epub 2006 May 9.

    PMID: 16683121BACKGROUND

  • Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390.

    PMID: 18777603BACKGROUND

  • Loupasis GA, Stamos K, Katonis PG, Sapkas G, Korres DS, Hartofilakidis G. Seven- to 20-year outcome of lumbar discectomy. Spine (Phila Pa 1976). 1999 Nov 15;24(22):2313-7. doi: 10.1097/00007632-199911150-00005.

    PMID: 10586454BACKGROUND

  • Asch HL, Lewis PJ, Moreland DB, Egnatchik JG, Yu YJ, Clabeaux DE, Hyland AH. Prospective multiple outcomes study of outpatient lumbar microdiscectomy: should 75 to 80% success rates be the norm? J Neurosurg. 2002 Jan;96(1 Suppl):34-44. doi: 10.3171/spi.2002.96.1.0034.

    PMID: 11795712BACKGROUND

  • Ivanic GM, Pink TP, Homann NC, Scheitza W, Goyal S. The post-discectomy syndrome. Aetiology, diagnosis, treatment, prevention. Arch Orthop Trauma Surg. 2001 Oct;121(9):494-500. doi: 10.1007/s004020100289.

    PMID: 11599749BACKGROUND

  • Hosseini S, Niakan A, Dehghankhalili M, Dehdab R, Shahjouei S, Rekabdar Y, Shaghaghian E, Shaghaghian A, Ghaffarpasand F. Effects of adhesion barrier gel on functional outcomes of patients with lumbar disc herniation surgery; A systematic review and meta-analysis of clinical trials. Heliyon. 2021 Jun 11;7(6):e07286. doi: 10.1016/j.heliyon.2021.e07286. eCollection 2021 Jun.

    PMID: 34189319BACKGROUND

  • BenDebba M, Augustus van Alphen H, Long DM. Association between peridural scar and activity-related pain after lumbar discectomy. Neurol Res. 1999;21 Suppl 1:S37-42. doi: 10.1080/01616412.1999.11741025.

    PMID: 10214570BACKGROUND

  • Ross JS, Robertson JT, Frederickson RC, Petrie JL, Obuchowski N, Modic MT, deTribolet N. Association between peridural scar and recurrent radicular pain after lumbar discectomy: magnetic resonance evaluation. ADCON-L European Study Group. Neurosurgery. 1996 Apr;38(4):855-61; discussion 861-3.

    PMID: 8692415BACKGROUND

  • Ivanic GM, Pink PT, Schneider F, Stuecker M, Homann NC, Preidler KW. Prevention of epidural scarring after microdiscectomy: a randomized clinical trial comparing gel and expanded polytetrafluoroethylene membrane. Eur Spine J. 2006 Sep;15(9):1360-6. doi: 10.1007/s00586-006-0120-1. Epub 2006 Jun 9.

    PMID: 16763848BACKGROUND

  • Guner D, Asik I, Ozgencil GE, Peker E, Erden MI. The Correlation of Epidural Fibrosis with Epiduroscopic and Radiologic Imaging for Chronic Pain after Back Surgery. Pain Physician. 2021 Dec;24(8):E1219-E1226.

    PMID: 34793648BACKGROUND

  • Wang H, Sun W, Fu D, Shen Y, Chen YY, Wang LL. Update on biomaterials for prevention of epidural adhesion after lumbar laminectomy. J Orthop Translat. 2018 Mar 7;13:41-49. doi: 10.1016/j.jot.2018.02.001. eCollection 2018 Apr.

    PMID: 29662790BACKGROUND

  • Gerszten PC, Moossy JJ, Flickinger JC, Welch WC. Low-dose radiotherapy for the inhibition of peridural fibrosis after reexploratory nerve root decompression for postlaminectomy syndrome. J Neurosurg. 2003 Oct;99(3 Suppl):271-7. doi: 10.3171/spi.2003.99.3.0271.

    PMID: 14563144BACKGROUND

  • Du X, Wu L, Yan H, Jiang Z, Li S, Li W, Bai Y, Wang H, Cheng Z, Kong D, Wang L, Zhu M. Microchannelled alkylated chitosan sponge to treat noncompressible hemorrhages and facilitate wound healing. Nat Commun. 2021 Aug 5;12(1):4733. doi: 10.1038/s41467-021-24972-2.

    PMID: 34354068BACKGROUND

  • Hajosch R, Suckfuell M, Oesser S, Ahlers M, Flechsenhar K, Schlosshauer B. A novel gelatin sponge for accelerated hemostasis. J Biomed Mater Res B Appl Biomater. 2010 Aug;94(2):372-379. doi: 10.1002/jbm.b.31663.

    PMID: 20578223BACKGROUND

  • Zhao YF, Zhao JY, Hu WZ, Ma K, Chao Y, Sun PJ, Fu XB, Zhang H. Synthetic poly(vinyl alcohol)-chitosan as a new type of highly efficient hemostatic sponge with blood-triggered swelling and high biocompatibility. J Mater Chem B. 2019 Mar 21;7(11):1855-1866. doi: 10.1039/c8tb03181a. Epub 2019 Feb 21.

    PMID: 32255048BACKGROUND

  • Ahn JH, Yoon SG, Yi JW, Kim SJ, Lee KE. Anti-adhesive effect and safety of a thermosensitive adhesion barrier (Mediclore) for thyroid surgery: a double-blinded randomized controlled trial. Ann Surg Treat Res. 2022 Jun;102(6):313-322. doi: 10.4174/astr.2022.102.6.313. Epub 2022 Jun 7.

    PMID: 35800997RESULT

  • Kim YI, Lee M, Kim SI, Seol A, Lee EJ, Kim HS, Song YS. A Randomized Controlled Trial of Thermo-Sensitive Sol-Gel Anti-Adhesion Agent after Gynecologic Surgery. J Clin Med. 2020 Jul 16;9(7):2261. doi: 10.3390/jcm9072261.

    PMID: 32708699RESULT

  • Chung JH, Kim KS, Choi JD, Kim TH, Lee KS, Oh CY, Noh JH, Kim JS, Kim WT, Lee SH, Kim JH, Kim TN, Huh W, Lee SW. Effects of poloxamer-based thermo-sensitive sol-gel agent on urethral stricture after transurethral resection of the prostate for benign prostatic hyperplasia: a multicentre, single-blinded, randomised controlled trial. BJU Int. 2020 Jan;125(1):160-167. doi: 10.1111/bju.14902. Epub 2019 Oct 6.

    PMID: 31444917RESULT

  • Choi HJ, Ryu JM, Chae BJ, Kim EK, Min JW, Shin HJ, Nam SJ, Yu J, Lee JE, Lee SK, Kim SW. Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial. J Breast Cancer. 2021 Aug;24(4):367-376. doi: 10.4048/jbc.2021.24.e30. Epub 2021 Jun 17.

    PMID: 34352935RESULT

  • Shin SJ, Lee JH, So J, Min K. Anti-adhesive effect of poloxamer-based thermo-sensitive sol-gel in rabbit laminectomy model. J Mater Sci Mater Med. 2016 Nov;27(11):162. doi: 10.1007/s10856-016-5773-7. Epub 2016 Sep 19.

    PMID: 27646404RESULT

  • Fransen P. Reduction of postoperative pain after lumbar microdiscectomy with DuraSeal Xact Adhesion Barrier and Sealant System. Spine J. 2010 Sep;10(9):751-61. doi: 10.1016/j.spinee.2010.05.001. Epub 2010 Jun 12.

    PMID: 20542472RESULT

  • Ross JS, Obuchowski N, Modic MT. MR evaluation of epidural fibrosis: proposed grading system with intra- and inter-observer variability. Neurol Res. 1999;21 Suppl 1:S23-6. doi: 10.1080/01616412.1999.11758604.

    PMID: 10214567RESULT

MeSH Terms

Conditions

Intervertebral disc diseaseFailed Back Surgery Syndrome

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Nattapat Tangchitcharoen, MD

CONTACT

6622565351t-nattapat@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow in Spine Surgery, Chulalongkorn University

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 13, 2023

Study Start

October 1, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)