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

December 3, 2023 updated by: D.med

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • ChoongChungBukDo
      • ChungJu, ChoongChungBukDo, Korea, Republic of
        • Chungbook National University Hospital
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, Korea, Republic of, 31116
        • Dankook University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active / control
One side has been treated with SurgiShield
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
No Intervention: No intervention
One side has no intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adhesion Rate
Time Frame: 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
at 1 and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D.med

Collaborators

Chungbuk National University
Dankook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimated)

July 11, 2013

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMED-SS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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