Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer

Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer A Multicenter Double-blinded, Randomized Study

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02967146

Enrollment

170

Registered

2016-11-18

Start date

2016-11-30

Completion date

Unknown

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

Breastcancer, Surgery: Axillary Dissection

Brief summary

Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and chitosan(Mediclore®) after axillary dissection for breast cancer

Detailed description

A Multicenter Double-blinded, Randomized Study

Interventions

DEVICEadhesive barrier

After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* the patients needed axillary dissection in breast cancer * Written informed consent * Patients without clinically significant lab * the patients who are diagnosed 'positive for metastasis' by sentinel lymph node biopsy

Exclusion criteria

* having enrolled another clinical trials within 1 month * Immunosuppression or autoimmune disease * Anticoagulant, general steroids within a week from surgery * Incompatible medications * Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)

Design outcomes

Primary

Measure	Time frame	Description
sum of ROM(range of motion)	4weeks	to compare the differences of sum of ROM between two groups comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction

Secondary

Measure	Time frame	Description
sum of ROM(range of motion)	24weeks	comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
pain assessment (numeric pain rating scale)	4weeks, 24weeks	to compare the differences of the pain related with motions of upper limbs
Scoring DASH(Disablities of the arm, shoulder and hand)	4weeks, 24weeks	to compare the differences of the DASH score

Countries

South Korea

Contacts

Primary ContactSeok won Kim, MD

seokwon1.kim@samsung.com+82-2-3410-2375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026