- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02141373
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
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 Contact
- Name: Mahmoud AlMasri, MD
- Phone Number: 009625300460
- Email: Malmasri@KHCC.JO
Study Locations
-
-
-
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
|
|
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
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.
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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