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

Yong Sang Song

Status and phase: Unknown; Phase 3

Conditions: Gynecologic Disease

Treatments: Device: Adept; Device: Mediclore

Study type: Interventional

Funder types: Other

Identifiers

NCT03007654

CG-AHS008

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 3 patient groups

Mediclore

Experimental group

Description:

adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area

Treatment:

Device: Mediclore

No treatment

No Intervention group

Description:

standard treatment for surgery

Adept

Active Comparator group

Description:

adhesion barrier, Adept, to apply medical device fully around surgery area

Treatment:

Device: Adept