None listed
Conditions
Interventions
Medical Device : Depending on the assignment group, the clinical trial medical device applies Mediclore or Guardix-SG up to 5cc of Mediclore and 6cc of Guardix-SG to the surgical site.
Sponsors
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects to be studied for thyroidectomy aged 19 to 65 2. Subjects with stage T1 and T2 (less than 4 cm without invasion of surrounding tissues) in case of suspected thyroid cancer in preoperative examination or those with nodules less than 4 cm in length by ultrasound if not suspected thyroid cancer in preoperative examination 3. A person who voluntarily signed a written consent form after hearing an explanation of the purpose, method, etc. of this clinical trial
Exclusion criteria
Exclusion criteria: 1. If lateral cervical lymph node resection is required 2. a pregnant woman 3. uncontrolled diabetes 4. chronic kidney failure 5. Past history of neck surgery 6. Mr. Graves, if you have a disease 7. If you have a chronic alcohol disease 8. If you have a vocal cord attack before surgery 9. If anticoagulants are administered within one week prior to surgery 10. In case of hypersensitivity or allergy to clinical trial medical device components (poloxamer, glycerol, gelatin, chitosan, acetic acid, sodium alginate) 11. If the medical staff expects it to be difficult to fill out the questionnaire on their own 12. Where the medical staff judges that it is difficult to participate in the study due to other underlying diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Swallowing Impairment Scores(SIS-6) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Swallowing Impairment Scores(SIS-6) score ;Voice Handicap Index-10 score;Glasgow-Edinburgh Throat Scale score;Objective Scar Wrinkle Assessment scroe | — |
Countries
Korea, Republic of
Contacts
Public ContactKim Eunji
CGBio
Outcome results
None listed