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

Primary Purpose

Wound Healing

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

5ml surgishield

About this trial

This is an interventional treatment trial for Wound Healing focused on measuring Investigational device (chitosan gel), Wound healing, Endoscopic sinus surgery, SurgiShield

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Chungbook National University Hospital
Dankook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Active / control

No intervention

Arm Description

One side has been treated with SurgiShield

One side has no intervention

Outcomes

Primary Outcome Measures

Adhesion Rate

Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01895933

First Posted

July 8, 2013

Last Updated

July 21, 2013

Sponsor

D.med

Collaborators

Dankook University, Chungbuk National University

1. Study Identification

Unique Protocol Identification Number

NCT01895933

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

D.med

Collaborators

Dankook University, Chungbuk National University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Healing

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active / control

Arm Type

Active Comparator

Arm Description

One side has been treated with SurgiShield

Arm Title

No intervention

Arm Type

No Intervention

Arm Description

One side has no intervention

Intervention Type

Device

Intervention Name(s)

5ml surgishield

Intervention Description

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

Primary Outcome Measure Information:

Title

Adhesion Rate

Description

Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)

Time Frame

at 2 weeks

Secondary Outcome Measure Information:

Title

Adhesion Rate

Description

Adhesion rate at 1 and 4 weeks after ESS(endoscopic sinus surgery) Bleeding score at 0,2,4,6,8,10 minutes after ESS

Time Frame

at 1 and 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Chungbook National University Hospital

City

ChungJu

State/Province

ChoongChungBukDo

Country

Korea, Republic of

Facility Name

Dankook University Hospital

City

ChunAhn

State/Province

ChoongChungNamDo

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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