This study was designed to demonstrate the non-inferiority of MEDICURTAIN® (investigational device) compared to commercially available GUARDIX-SG® (control device) in treatment of subject who underwent total thyroidectomy for prevention of adhesion formation at 6 weeks after the surgery.
This clinical trial is a randomized, multi center, subject and evaluator blinded, parallel, comparative and non-inferiority clinical trial study to assess the prevention of adhesion formation in the subjects treated either MEDICURTAIN® or GUARDIX-SG at 6 weeks after total thyroidectomy. The primary endpoint was defined as abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography. The objective of this study was to demonstrate the non-inferiority of investigational device versus control device for adhesion formation at 6 weeks after the administration of investigational or control devices. Esophageal motility score and clinical symptoms assessed by the independent third evaluator using marshmallow esophagography at 6 weeks after administration of investigational device were secondary outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
170
GUARDIX-SG® 6g prefilled syringe
Medicurtain® 5ml prefilled syringe
Ewha Womans University Mokdong Hospital
Seoul, Gangnam-gu, Eonju-ro, 211, South Korea
Presence of abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device.
The percentage of abnormal findings measured as mild/moderate/severe in the esophageal motor performance score through marshmallow esophagography is the incidence of adhesion. The esophageal motility was scored as normal 3 point, mild 2 point, moderate 1 point and severe 0 point.
Time frame: Week 6
Esophageal motility score assessed by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device
The esophageal motility was scored as normal 3 point, mild 2 point, moderate 1 point and severe 0 point.
Time frame: Week 6
Clinical Symptoms assessed using questionnaire by investigator assessed by using 10 point visual analogue scale (VAS).
The questionnaire is composed of three questions as shown below. 1. Discomfort around surgical area 2. Discomfort when a patient bends his or her neck backward 3. Inflammation reaction and scar formation around surgical area Each item is evaluated in the 10-step evaluation of VAS. 0 = None of pain, 10 = Agonizing.
Time frame: Follows up to week 6
Clinical Symptoms assessed using questionnaire by subject assessed by using 10 point visual analogue scale (VAS).
The questionnaire is composed of four questions as shown below. 1. Difficulty in swallowing the saliva 2. Difficulty in swallowing the water 3. Difficulty in swallowing the solid food 4. Aesthetic self-satisfaction on the scar around surgical area Each item is evaluated in the 10-step evaluation of VAS. 0 = None of pain, 10 = Agonizing.
Time frame: Follows up to week 6
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