Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
1 other identifier
interventional
136
1 country
1
Brief Summary
Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
May 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedApril 3, 2015
April 1, 2015
2 years
April 9, 2014
April 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total drainage volume
3 months
Total seroma aspirate volume
3 months
Secondary Outcomes (5)
Adverse events
3 months
Duration of fluid drainage
3 months
Time to drain removal
3 months
Number of seroma aspirations
3 months
Additional costs incurred due to the need of aspirations
3 months
Study Arms (2)
Glubran 2
EXPERIMENTALGlubran 2 will be used at end of surgery
Standard Surgery
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Hussein Cancer Center
Amman, 1269 /11941, Jordan
Related Publications (1)
Al-Masri M, Alawneh F, Daoud F, Ebous A, Hamdan B, Al-Najjar H, Al-Masri R, Abufara M. Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial. Front Oncol. 2021 Jan 25;10:580861. doi: 10.3389/fonc.2020.580861. eCollection 2020.
PMID: 33569343DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud Al Masri, MD
King Hussein Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman, Department of Surgery
Study Record Dates
First Submitted
April 9, 2014
First Posted
May 19, 2014
Study Start
October 1, 2013
Primary Completion
October 1, 2015
Last Updated
April 3, 2015
Record last verified: 2015-04