Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection

April 2, 2015 updated by: Mahmoud Al-Masri, King Hussein Cancer Center
Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 1269 /11941
        • Recruiting
        • King Hussein Cancer Center
        • Sub-Investigator:
          • Faiez Daoud, MD
        • Sub-Investigator:
          • Mohammed Hamdan, MD
        • Principal Investigator:
          • Mahmoud Al-Masri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The Patient should be above 18 years old
  • The Patients has Node positive breast cancer
  • The Patient is eligible for axillary dissection in addition to a surgical intervention for the primary tumor
  • Patients whose sentinel lymph nodes test positive during surgery.
  • The patient is willing to sign an informed consent to participation

Exclusion Criteria:

  • Platelet count is less than 100000
  • Obese patients with a BMI of more than 35
  • Patients who need immediate breast reconstruction surgery
  • Patients who are receiving anticoagulation therapy or have coagulation disorders
  • Pregnant or lactating patients
  • Patients who are on steroid therapy
  • Patients who received chest radiotherapy
  • Patients who received neoadjuvant chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glubran 2
Glubran 2 will be used at end of surgery
Device: Glubran 2
NO_INTERVENTION: Standard Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total drainage volume
Time Frame: 3 months
3 months
Total seroma aspirate volume
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 3 months
3 months
Duration of fluid drainage
Time Frame: 3 months
3 months
Time to drain removal
Time Frame: 3 months
3 months
Number of seroma aspirations
Time Frame: 3 months
3 months
Additional costs incurred due to the need of aspirations
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Hussein Cancer Center

Investigators

  • Principal Investigator: Mahmoud Al Masri, MD, King Hussein Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2015

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (ESTIMATE)

May 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRT-CTU-0912/03 Version 5.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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