Back to resultsEfficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pivotal Study)
Primary Purpose
Sinusitis, Tissue Adhesion, Surgery-Induced
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Medicurtain®
GUARDIX-SG®
Sponsored by
About this trial
This is an interventional prevention trial for Sinusitis focused on measuring Medicurtain®, Sodium hyaluronate, Anti-adhesion barrier
Eligibility Criteria
Inclusion Criteria:
- Patients at the age of between 19 and 69
- Patients scheduled for surgery with chronic or relapsed sinusitis not responding to drug therapy (Verification to be made based on past clinical history, physical examination and radiography)
- Patients with the discrepancy of Lund-MacKay CT scan scores on bilateral sinusitis less than 3
- Patients who signed written consent after listening to the objective, method and effects of clinical trial
- Patients available during the period of clinical trial
Exclusion Criteria:
- Patients with sinusitis on only one nasal cavity
- Patients with massive sinonasal polyposis
- Patients with one or both middle turbinate removed, in addition to a history of endoscopic surgery or polyp operation
- Patients with ongoing drug administration for asthma
- Patients with immune disorders which may potentially hinder healing of the wounds including acquired immunodeficiency syndrome, cystofibroma, immotile cilia syndrome, neutropenia and immune globulin deficiency
- Patients with immunosuppression or autoimmune disease
- Patients with hypersensitivity reaction to Poloxamer and Hyaluronic acid
- Patients who had surgery to treat extrasinus complication from rhinosinusitis
- Patients with history of endoscopic sinus surgery for other than chronic or relapsed sinusitis, including cerebrospinal fluid (CSF) leak correction, orbital decompression and optic nerve decompression
- Patients with significant liver or kidney diseases
- Patients with setting agent administered or with hemostatic or lymph fluid disorders
- Patients administered with oral or parenteral drugs for hypoglycemia
- Patients with significant systematic disease
- Patients with malignant tumor
- Patients with infectious disease or suspected of potential problems during the course of healing surgical site (healing disorder)
- Those who are pregnant or lactiferous
- Women of childbearing age with plan for pregnancy during the clinical trial period
- Those who participated in other clinical trials 30 days prior to the participation in this trial
- In addition to the above, those who are subject to clinical findings where principal investigator or sub-investigator deem inadequate for this clinical trial based on medical judgment
Sites / Locations
- Korea University Guro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medicurtain®
GUARDIX-SG®
Arm Description
Treat GUARDIX-SG 5ml prefilled syringe after surgery
Treat Medicurtain® 5ml prefilled syringe after surgery
Outcomes
Primary Outcome Measures
Difference between effective ratio (Pt=P00+P01) of medical device for clinical trial and effective ratio (Pc=P00+P10) of medical device for control test evaluated by independent assessor at the 4th week following the application of medical device
P00: Ratio of study subjects without adhesion at the application site with medical devices for clinical trial and control test
P01: Ratio of study subjects without adhesion only at the application site with medical device for clinical trial
P10: Ratio of study subjects without adhesion only at the application site with medical device for control trial
Secondary Outcome Measures
Ratio of study subjects without adhesion and extent of adhesion evaluated by independent assessor
Adhesion is to be scored and recorded on the scale of 0 to 3 points, where the adhesion requiring treatments shall be scored at 2 points or higher. Independent assessor must be blind.
* Standard for grading score of Synechia
Score 0: Synechia not visible
Score 1: One or a few synechia are visible, but clear hindrance obstructing sinus ventilation is not detected.
Score 2: Presence of Synechia obstructing sinus ventilation and drainage.
Score 3: Formation of complete scar between middle turbinate and lateral wall of nose.
Ratio of study subjects without adhesion and extent of adhesion evaluated by investigator
Adhesion is to be scored and recorded on the scale of 0 to 3 points, where the adhesion requiring treatments shall be scored at 2 points or higher. Investigator is open-state.
Presence of adhesion (decomposition or dissolution) requiring treatments at 4th week
Rate of patient who received 2 or more point in the adhesion assessment with medical devices for clinical trial or control test.
Ratio of study subjects without edema and the extent of edema evaluated at each visit
Edema is to be score and record at the scale of 0 to 3 points, depending on the extensiveness where the case requiring treatments for edema with steroids shall be scored at 2 points or higher.
* Standard for grading score of Edema
Score 0: Mucous membrane edema not visible
Score 1: Mild mucous membrane edema without extinction of ethmoid sinus
Score 2: Serious mucous membrane edema with extinction of most ethmoid sinus
Score 3: Parenchymatous polyposis
Presence of edema requiring treatment evaluated at each visit (Only the cases using oral steroid not for prevention purpose but for treatment purpose)
Rate of patient who received 2 or more point in the edema assessment with medical devices for clinical trial or control test.
Ratio of study subjects without local infection and extent of local infection evaluated at each visit
Infection is to be scored and recorded at the scale of 0 to 2 points where the case requiring treatments for infection shall be scored at 2 points.
* Standard for grading score of Infection
Score 0: Proof of infection not visible
Score 1: Drainage of mild mucopurulent
Score 2: Drainage of lumpy mucopurulent accompanying parenchymatous infection
Presence of infection requiring treatment evaluated at each visit (Only the cases using antibiotics not for prevention purpose but for treatment purpose)
Rate of patient who received 2 or more point in the infection assessment with medical devices for clinical trial or control test.
Full Information
NCT ID
NCT05049434
First Posted
September 10, 2021
Last Updated
September 10, 2021
Sponsor
Shin Poong Pharmaceutical Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05049434
Brief Title
Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pivotal Study)
Official Title
A Multi Center, Randomized, Single Blind, Assessor Blind, Matched Pair Design Clinical Study to Evaluate the Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2014 (Actual)
Primary Completion Date
March 31, 2015 (Actual)
Study Completion Date
March 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Poong Pharmaceutical Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis, Tissue Adhesion, Surgery-Induced
Keywords
Medicurtain®, Sodium hyaluronate, Anti-adhesion barrier
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Evaluator-blinded
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medicurtain®
Arm Type
Experimental
Arm Description
Treat GUARDIX-SG 5ml prefilled syringe after surgery
Arm Title
GUARDIX-SG®
Arm Type
Active Comparator
Arm Description
Treat Medicurtain® 5ml prefilled syringe after surgery
Intervention Type
Device
Intervention Name(s)
Medicurtain®
Intervention Description
Medicurtain® 5ml prefilled syringe
Intervention Type
Device
Intervention Name(s)
GUARDIX-SG®
Intervention Description
GUARDIX-SG® 5ml prefilled syringe
Primary Outcome Measure Information:
Title
Difference between effective ratio (Pt=P00+P01) of medical device for clinical trial and effective ratio (Pc=P00+P10) of medical device for control test evaluated by independent assessor at the 4th week following the application of medical device
Description
P00: Ratio of study subjects without adhesion at the application site with medical devices for clinical trial and control test
P01: Ratio of study subjects without adhesion only at the application site with medical device for clinical trial
P10: Ratio of study subjects without adhesion only at the application site with medical device for control trial
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Ratio of study subjects without adhesion and extent of adhesion evaluated by independent assessor
Description
Adhesion is to be scored and recorded on the scale of 0 to 3 points, where the adhesion requiring treatments shall be scored at 2 points or higher. Independent assessor must be blind.
* Standard for grading score of Synechia
Score 0: Synechia not visible
Score 1: One or a few synechia are visible, but clear hindrance obstructing sinus ventilation is not detected.
Score 2: Presence of Synechia obstructing sinus ventilation and drainage.
Score 3: Formation of complete scar between middle turbinate and lateral wall of nose.
Time Frame
follow up to 4weeks
Title
Ratio of study subjects without adhesion and extent of adhesion evaluated by investigator
Description
Adhesion is to be scored and recorded on the scale of 0 to 3 points, where the adhesion requiring treatments shall be scored at 2 points or higher. Investigator is open-state.
Time Frame
follow up to 4weeks
Title
Presence of adhesion (decomposition or dissolution) requiring treatments at 4th week
Description
Rate of patient who received 2 or more point in the adhesion assessment with medical devices for clinical trial or control test.
Time Frame
follow up to 4weeks
Title
Ratio of study subjects without edema and the extent of edema evaluated at each visit
Description
Edema is to be score and record at the scale of 0 to 3 points, depending on the extensiveness where the case requiring treatments for edema with steroids shall be scored at 2 points or higher.
* Standard for grading score of Edema
Score 0: Mucous membrane edema not visible
Score 1: Mild mucous membrane edema without extinction of ethmoid sinus
Score 2: Serious mucous membrane edema with extinction of most ethmoid sinus
Score 3: Parenchymatous polyposis
Time Frame
follow up to 4weeks
Title
Presence of edema requiring treatment evaluated at each visit (Only the cases using oral steroid not for prevention purpose but for treatment purpose)
Description
Rate of patient who received 2 or more point in the edema assessment with medical devices for clinical trial or control test.
Time Frame
follow up to 4weeks
Title
Ratio of study subjects without local infection and extent of local infection evaluated at each visit
Description
Infection is to be scored and recorded at the scale of 0 to 2 points where the case requiring treatments for infection shall be scored at 2 points.
* Standard for grading score of Infection
Score 0: Proof of infection not visible
Score 1: Drainage of mild mucopurulent
Score 2: Drainage of lumpy mucopurulent accompanying parenchymatous infection
Time Frame
follow up to 4weeks
Title
Presence of infection requiring treatment evaluated at each visit (Only the cases using antibiotics not for prevention purpose but for treatment purpose)
Description
Rate of patient who received 2 or more point in the infection assessment with medical devices for clinical trial or control test.
Time Frame
follow up to 4weeks
Other Pre-specified Outcome Measures:
Title
The incidence rate of adverse events (AEs)
Description
Safety and tolerability by collecting AEs
Time Frame
follow up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients at the age of between 19 and 69
Patients scheduled for surgery with chronic or relapsed sinusitis not responding to drug therapy (Verification to be made based on past clinical history, physical examination and radiography)
Patients with the discrepancy of Lund-MacKay CT scan scores on bilateral sinusitis less than 3
Patients who signed written consent after listening to the objective, method and effects of clinical trial
Patients available during the period of clinical trial
Exclusion Criteria:
Patients with sinusitis on only one nasal cavity
Patients with massive sinonasal polyposis
Patients with one or both middle turbinate removed, in addition to a history of endoscopic surgery or polyp operation
Patients with ongoing drug administration for asthma
Patients with immune disorders which may potentially hinder healing of the wounds including acquired immunodeficiency syndrome, cystofibroma, immotile cilia syndrome, neutropenia and immune globulin deficiency
Patients with immunosuppression or autoimmune disease
Patients with hypersensitivity reaction to Poloxamer and Hyaluronic acid
Patients who had surgery to treat extrasinus complication from rhinosinusitis
Patients with history of endoscopic sinus surgery for other than chronic or relapsed sinusitis, including cerebrospinal fluid (CSF) leak correction, orbital decompression and optic nerve decompression
Patients with significant liver or kidney diseases
Patients with setting agent administered or with hemostatic or lymph fluid disorders
Patients administered with oral or parenteral drugs for hypoglycemia
Patients with significant systematic disease
Patients with malignant tumor
Patients with infectious disease or suspected of potential problems during the course of healing surgical site (healing disorder)
Those who are pregnant or lactiferous
Women of childbearing age with plan for pregnancy during the clinical trial period
Those who participated in other clinical trials 30 days prior to the participation in this trial
In addition to the above, those who are subject to clinical findings where principal investigator or sub-investigator deem inadequate for this clinical trial based on medical judgment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heung-Man Lee, MD
Organizational Affiliation
Korea University, Guro Hospital 148 Gurodong-ro, Guro-gu, Seoul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyung-su Kim, MD
Organizational Affiliation
Gangnam Severance Hospital Yonsei University, 146-92 Dogok-dong, Gangnam-gu, Seoul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pivotal Study)
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