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

D.med

Status

Completed

Conditions

Wound Healing

Treatments

Device: 5ml surgishield

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01895933

DMED-SS001

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

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