Efficacy and Safety of the Investigational Device, SurgiS... | NCT01895933

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

NCT01895933

Sponsor

D.med

Status

Completed

Last Update Posted

Dec 8, 2023Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Wound Healing

Interventions

5ml surgishield

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jul 8, 2013

First Submission Date that Met QC Criteria

Jul 10, 2013

First Posted Date

Jul 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2023

Last Update Posted Date

Dec 8, 2023Actual

Name	Class
Dankook University	OTHER
Chungbuk National University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active / control	Active Comparator	One side has been treated with SurgiShield	Device: 5ml surgishield
No intervention	No Intervention	One side has no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5ml surgishield	Device	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chungbook National University Hospital		Chungju	ChoongChungBukDo		South Korea
Dankook University Hospital