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

NCT01895933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-12-08

No results posted yet for this study

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.

Conditions

  • Wound Healing

Interventions

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

Sponsors & Collaborators

  • Dankook University

    collaborator OTHER

  • Chungbuk National University

    collaborator OTHER

  • D.med

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895933 on ClinicalTrials.gov