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

Not Applicable

Completed

• Conditions: Wound Healing
• Interventions: Device: 5ml surgishield

• Registration Number: NCT01895933
• Lead Sponsor: D.med

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active / control	5ml surgishield	One side has been treated with SurgiShield

Primary Outcome Measures

Name	Time	Method
Adhesion Rate	at 2 weeks	Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)

Secondary Outcome Measures

Name	Time	Method
Adhesion Rate	at 1 and 4 weeks	Adhesion rate at 1 and 4 weeks after ESS(endoscopic sinus surgery) Bleeding score at 0,2,4,6,8,10 minutes after ESS

Trial Locations

Locations (2)

Chungbook National University Hospital; 🇰🇷 ChungJu, ChoongChungBukDo, Korea, Republic of

Dankook University Hospital; 🇰🇷 Cheonan, Chungcheongnam-do, Korea, Republic of