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

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ClinicalTrials.gov Identifier: NCT03007654
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Yong Sang Song, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gynecologic Disease Device: Mediclore Device: Adept Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : December 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Mediclore
adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area
Device: Mediclore
apply medical device fully around intrauterine surgery area
Other Name: 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
Device: Adept
apply medical device fully around intrauterine surgery area




Primary Outcome Measures :
  1. adhesion rate [ Time Frame: 4 weeks after surgery ]
    4 weeks after surgery, finding adhesion using visceral slide test


Secondary Outcome Measures :
  1. Incidence of adhesion symptoms [ Time Frame: 4 weeks after surgery ]
    4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire

  2. adverse event [ Time Frame: 4 weeks after surgery ]
    identifying adverse events after surgery



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007654


Contacts
Contact: Yongsang Song, MD +82-10-9580-1023 yssong@snu.ac.kr
Contact: Maria Lee, MD +82-10-2991-9692 marialee@snu.ac.kr

Locations
Korea, Republic of
Seoutl National University Hospital Recruiting
Seoul City, Korea, Republic of
Contact: Yong sang Song, MD    +82-10-9580-1023      
Contact: Maria Lee, MD    +82-10-2991-9692    marialee@snu.ac.kr   
Sponsors and Collaborators
Yong Sang Song

Responsible Party: Yong Sang Song, MD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03007654     History of Changes
Other Study ID Numbers: CG-AHS008
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Genital Diseases, Female
Chitosan
Icodextrin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants
Dialysis Solutions
Pharmaceutical Solutions