Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel
NCT ID: NCT01895933
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2012-03-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active / control
One side has been treated with SurgiShield
5ml surgishield
in the case of active, apply solution type adhesion barrier to merocel and pack 5ml of adhesion inhibitor Surgi Shield on the surgical site
merocel in the inflated state maintained for 36\~48 hours, remove packing then solution type adhesion inhibitor is to be injected in to the surgical site
No intervention
One side has no intervention
No interventions assigned to this group
Interventions
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5ml surgishield
in the case of active, apply solution type adhesion barrier to merocel and pack 5ml of adhesion inhibitor Surgi Shield on the surgical site
merocel in the inflated state maintained for 36\~48 hours, remove packing then solution type adhesion inhibitor is to be injected in to the surgical site
Eligibility Criteria
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Inclusion Criteria
* both side sinusitis
* will undergo endoscopic sinus surgery
* volunteers with informed consent and signature
Exclusion Criteria
* systemic grave condition
* pregnant
* cancer
* severe disease patients
* asthma patients
* AIDS
* cystic fibrosis
* ciliary immobility syndrome
* neutropenia neutrophil
* immunoglobulin deficiency
* wound healing immune disease
* severe liver disease
* severe kidney disease
* lymph or blood clotting disorder or patients treated with coagulants
* patients taking oral or parenteral glucose for diabetes thrombocytopenia
* infectious disease
* currently lactating
* severe septal deviation
* case where there is a severe difference in sinusitis state between sides of nose: there is a 3 or more score difference on the Lund-Mackey CT scan scoring system PNS(ParaNasalSinus)
* shellfish allergy
* food allergy
* had endoscopic sinus surgery in the past
* patient with large sinus polyps
* patients who have received treatment for extrasinus complication
21 Years
70 Years
ALL
No
Sponsors
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Dankook University
OTHER
Chungbuk National University
OTHER
D.med
INDUSTRY
Responsible Party
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Locations
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Chungbook National University Hospital
Chungju, ChoongChungBukDo, South Korea
Dankook University Hospital
Cheonan, Chungcheongnam-do, South Korea
Countries
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Other Identifiers
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DMED-SS001
Identifier Type: -
Identifier Source: org_study_id