Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) (antiadhesion)

January 3, 2017 updated by: Yong Sang Song

Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study

The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

  • Name: Yongsang Song, MD
  • Phone Number: +82-10-9580-1023
  • Email: yssong@snu.ac.kr

Study Contact Backup

Study Locations

      • Seoul City, Korea, Republic of
        • Recruiting
        • Seoutl National University Hospital
        • Contact:
        • Contact:
          • Yong sang Song, MD
          • Phone Number: +82-10-9580-1023

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with Gynecological disease (benign disease)
  • Patients who Written informed consent
  • Patients without clinically significant lab

Exclusion Criteria:

  • having enrolled another clinical trials within 1 month
  • Immunosuppression or autoimmune disease
  • Anticoagulant, general steroids within a week from surgery
  • Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
  • Patients with previous history of surgery at the same operate site

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediclore
adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area
apply medical device fully around intrauterine surgery area
Other Names:
  • Poloxamer, Gelatin and Chitosan.
No Intervention: No treatment
standard treatment for surgery
Active Comparator: Adept
adhesion barrier, Adept, to apply medical device fully around surgery area
apply medical device fully around intrauterine surgery area

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adhesion rate
Time Frame: 4 weeks after surgery
4 weeks after surgery, finding adhesion using visceral slide test
4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adhesion symptoms
Time Frame: 4 weeks after surgery
4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire
4 weeks after surgery
adverse event
Time Frame: 4 weeks after surgery
identifying adverse events after surgery
4 weeks after surgery

Collaborators and Investigators

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

Sponsor

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

December 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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