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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01895933

Enrollment

Registered

2013-07-11

Start date

2012-03-31

Completion date

2013-04-30

Last updated

2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Healing

Keywords

Investigational device (chitosan gel), Wound healing, Endoscopic sinus surgery, SurgiShield

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.

Interventions

DEVICE5ml 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Adhesion Rate	at 2 weeks	Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026