Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel

Study Overview
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Brief Summary
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This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after endoscopic sinus surgery.

Official Title
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The Aim of This Study is to Evaluate the Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel Made by D Med

Conditions
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Wound Healing

Intervention / Treatment
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* Device: 5ml surgishield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: older than 21 years of age both side sinusitis will undergo endoscopic sinus surgery volunteers with informed consent and signature Exclusion Criteria: suppressed immunity patient 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active / control<br>One side has been treated with SurgiShield | Device: 5ml surgishield<br>* 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<br>|
| No Intervention: No intervention<br>One side has no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion Rate | Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery) | at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion Rate | Adhesion rate at 1 and 4 weeks after ESS(endoscopic sinus surgery) Bleeding score at 0,2,4,6,8,10 minutes after ESS | at 1 and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Investigational device (chitosan gel), Wound healing, Endoscopic sinus surgery, SurgiShield