Status:
COMPLETED
Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel
Lead Sponsor:
D.med
Collaborating Sponsors:
Dankook University
Chungbuk National University
Conditions:
Wound Healing
Eligibility:
All Genders
21-70 years
Phase:
NA
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 sur...
Eligibility Criteria
Inclusion
- older than 21 years of age
- both side sinusitis
- will undergo endoscopic sinus surgery
- volunteers with informed consent and signature
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01895933
Start Date
March 1 2012
End Date
April 1 2013
Last Update
December 8 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Chungbook National University Hospital
Chungju, ChoongChungBukDo, South Korea
2
Dankook University Hospital
Cheonan, Chungcheongnam-do, South Korea, 31116