NCT03007654UnknownPhase 3
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
Yong Sang Song1 site in 1 country192 target enrollmentStarted: December 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- adhesion rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Mediclore
Experimental
adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area
Intervention: Mediclore (Device)
No treatment
No Intervention
standard treatment for surgery
Adept
Active Comparator
adhesion barrier, Adept, to apply medical device fully around surgery area
Intervention: Adept (Device)
Outcomes
Primary Outcomes
adhesion rate
Time Frame: 4 weeks after surgery
4 weeks after surgery, finding adhesion using visceral slide test
Secondary Outcomes
- Incidence of adhesion symptoms(4 weeks after surgery)
- adverse event(4 weeks after surgery)
Investigators
Yong Sang Song
MD
Seoul National University Hospital
Study Sites (1)
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