Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pivotal Study)
Condition: Sinusitis; Tissue Adhesion, Surgery-Induced
MeSH terms: Sinusitis; Tissue Adhesions
Study type: Interventional

Summary: 
      This clinical trial is to prove that the treatment group of Medicurtain® is non-inferior to
      the treatment group of Guardix-sol®, test equipment on adhesion after endoscopic sinus
      surgery, upon the aspects of adhesion prevention efficacy and safety.
    

Detailed description: 
      This clinical trial was conducted based on multi center, randomized, assessor blind, matched
      pair design, active-controlled clinical study. After signing consent and fulfilling the
      standards for selection/exclusion, test subjects went through required treatments following
      endoscopic surgery; subsequently, according to the order of registration after 2 to 3 days
      from the surgery, the subjects were applied with a medical device for the clinical test and a
      medical device for the control test to both of their nasal cavities based on randomization.

      For procedures, bleeding was treated and prevented through packing, by soaking Merocel with
      saline solution following the ESS (Endoscopic sinus surgery) on subjects; and after 2 to 3
      days (or upon discharge), it was to treat applied regions of the subjects with assigned
      medical device after confirming sufficient hemostasis by removing Merocel. Being matched pair
      active-controlled clinical study, this clinical trial was designed to treat a single subject
      with both medical devices for clinical test and control test where it was kept unknown which
      device would be assigned to which nasal cavity based on randomization until the procedure was
      actually performed. For the time and method of evaluation, observation and evaluation were
      allowed to be conducted based on the images through endoscopy when subjects visited at 1st,
      2nd and 4th weeks following the treatment with medical device. The process of procedure was
      assured for an identical researcher to perform procedures in order to minimize the effect
      from the procedure method.

      All endoscopic image records of test subjects were delivered by independent assessors, while
      information on medical device used for treatment was excluded; and independent assessors
      evaluated each image record according to the evaluation standards prescribed by this clinical
      trial.

      Based on the determination of the researcher during and following the surgery, subjects were
      administered with 2nd or 3rd generation Cephalosporin Antibiotics. Following the surgery,
      subjects were instructed to use normal saline solution nasal spray 2 to 3 times a day on both
      nasal cavities by utilizing bulb-shape tube or syringe. In addition, subjects were also
      instructed to use intranasal steroid sprays.
    

Intervention name(s): Medicurtain®; GUARDIX-SG®
Intervention type(s): Device; Device
Intervention description(s): Medicurtain® 5ml prefilled syringe; GUARDIX-SG® 5ml prefilled syringe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Medicurtain®; Sodium hyaluronate; Anti-adhesion barrier