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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

Who can participate

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

Inclusion criteria

  • planned to perform thyroidectomy due to thyroid nodule
  • no evidence of distant metastasis 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
04

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

05

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

06

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03293186
Lead sponsor
Seoul National University Hospital
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 ↗

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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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