Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)
Phase 3
- Conditions
- Gynecologic Disease
- Interventions
- Device: MedicloreDevice: Adept
- Registration Number
- NCT03007654
- Lead Sponsor
- Yong Sang Song
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 192
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mediclore Mediclore adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area Adept Adept adhesion barrier, Adept, to apply medical device fully around surgery area
- Primary Outcome Measures
Name Time Method adhesion rate 4 weeks after surgery 4 weeks after surgery, finding adhesion using visceral slide test
- Secondary Outcome Measures
Name Time Method Incidence of adhesion symptoms 4 weeks after surgery 4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire
adverse event 4 weeks after surgery identifying adverse events after surgery
Trial Locations
- Locations (1)
Seoutl National University Hospital
🇰🇷Seoul City, Korea, Republic of