Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)
Phase 3
- Conditions
- Gynecologic Disease
- 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
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which Poloxamer, Gelatin and Chitosan in Mediclore® prevent intraperitoneal adhesion formation post-gynecological surgery?
How does the anti-adhesive efficacy of Mediclore® compare to standard-of-care barriers like Adept in preventing post-gynecological surgery adhesions?
What biomarkers could predict response to Mediclore® in patients undergoing gynecological surgery for conditions such as endometriosis or pelvic inflammatory disease?
What are the known adverse events associated with Poloxamer-Gelatin-Chitosan mixed solid use in intraperitoneal applications and how are they managed?
Are there any combination approaches or competitor drugs to Mediclore® that enhance anti-adhesion outcomes in gynecological procedures?
Trial Locations
- Locations (1)
Seoutl National University Hospital
🇰🇷Seoul City, Korea, Republic of
Seoutl National University Hospital🇰🇷Seoul City, Korea, Republic ofYong sang Song, MDContact+82-10-9580-1023Maria Lee, MDContact+82-10-2991-9692marialee@snu.ac.kr