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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03007654

Acronym

antiadhesion

Enrollment

192

Registered

2017-01-02

Start date

2016-12-31

Completion date

2017-08-31

Last updated

2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Disease

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.

Interventions

DEVICEMediclore

apply medical device fully around intrauterine surgery area

DEVICEAdept

apply medical device fully around intrauterine surgery area

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
adhesion rate	4 weeks after surgery	4 weeks after surgery, finding adhesion using visceral slide test

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactYongsang Song, MD

yssong@snu.ac.kr+82-10-9580-1023

Backup ContactMaria Lee, MD

marialee@snu.ac.kr+82-10-2991-9692

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026