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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Regenerative Collagen Scaffold for Breast Volume Restoration in Breast-Conserving Surgery

NCT07219316

Breast-Conserving Surgery

RECRUITING NA

Breast Mesh Used in Two-staged Breast Reconstruction

NCT04967976

Breast Cancer Radiation Breast Reconstruction +1 more

RECRUITING NA

Use of Microporous Polysaccharide Hemispheres in Breast Cancer Patients Undergoing Mastectomy

NCT06824831

Mastectomy Lymphadenectomy Breast Neoplasm Malignant Female +2 more

COMPLETED PHASE4

Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients

NCT06243796

Breast-cancer

COMPLETED NA

Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure

NCT01731769

Breast Neoplasms

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A Multicenter Double-blinded, Randomized Study

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breastcancer Surgery: Axillary Dissection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mediclore

Group Type EXPERIMENTAL

adhesive barrier

Intervention Type DEVICE

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

Not done

Standard treatment for surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

adhesive barrier

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No