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CompletedNCT03293186Updated Mar 17, 2021

Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)"

A Phase 4 interventional study of MEDICLORE in Adhesion and Thyroidectomy, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

One of most important complication of thyroid surgery is adhesion. There are many anti-adhesive materials, but none of them showed significant outcomes. The investigators planned double blind prospective study of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" to reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.

02

Conditions studied

  • Adhesion
  • Thyroidectomy

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03

In context

Tissue Adhesions

121 studies on the registry are indexed under Tissue Adhesions; 15 are open to participants now.

This study's enrollment of 90 is above the median of 61 across 84 interventional studies indexed under Tissue Adhesions.

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Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • planned to perform thyroidectomy due to thyroid nodule
  • no evidence of distant or invasion to adjacent organ in thyroid cancer
  • normal preoperative vocal cord movement
  • normal preoperative laboratory study

Exclusion criteria

Exclusion Criteria:

  • uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy
  • history of keloid or hypertrophic scar
  • Graves disease or hashimoto thyroiditis patients
  • aspirin or anticoagulant medication within 7 days
  • radiation exposure to the head and neck
  • previous operation to the neck
  • history of allergic reaction to drugs
  • pregnant women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Use MEDICLORE

    use mediclore at the end of surgery

    Combination Product: MEDICLORE

  • No intervention
    No antiadhesive product

    use no antiadhesive product at the end of surgery

Interventions

  • Combination productMEDICLORE

    use MEDICLORE at the end of surgery as antiadhesive product

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What researchers measure

Primary outcomes

  1. Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.

    Time frame: Participants will be followed from the operation to postoperative 2weeks, 3months, 6months

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Dec 2020, 41 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2017
First posted
Sep 26, 2017
StartActual
Jul 1, 2017
Primary completionActual
Dec 27, 2020
CompletionActual
Dec 31, 2020
Last update
Mar 17, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03293186
Responsible party
Su-jin Kim (Associate professor, Seoul National University Hospital) — Principal investigator
First posted
Sep 26, 2017
Start date
Jul 1, 2017
Primary completion
Dec 27, 2020
Completion
Dec 31, 2020
Last update
Mar 17, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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