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

Wound Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895933
• Other study ID #: DMED-SS001
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2023
• Source: D.med
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tissue Adhesions
• Wound Healing

Intervention

Device:
• 5ml 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

Locations

Country	Name	City	State
Korea, Republic of	Dankook University Hospital	Cheonan	Chungcheongnam-do
Korea, Republic of	Chungbook National University Hospital	ChungJu	ChoongChungBukDo

Sponsors (3)

Lead Sponsor	Collaborator
D.med	Chungbuk National University, Dankook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhesion Rate	Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)	at 2 weeks
Secondary	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