Back to resultsEffectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Glubran 2
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring seroma, axillary, dissection
Eligibility Criteria
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
Sites / Locations
- King Hussein Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Glubran 2
Standard Surgery
Arm Description
Glubran 2 will be used at end of surgery
Outcomes
Primary Outcome Measures
Total drainage volume
Total seroma aspirate volume
Secondary Outcome Measures
Adverse events
Duration of fluid drainage
Time to drain removal
Number of seroma aspirations
Additional costs incurred due to the need of aspirations
Full Information
NCT ID
NCT02141373
First Posted
April 9, 2014
Last Updated
April 2, 2015
Sponsor
King Hussein Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02141373
Brief Title
Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
Official Title
Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Hussein Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
seroma, axillary, dissection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glubran 2
Arm Type
Experimental
Arm Description
Glubran 2 will be used at end of surgery
Arm Title
Standard Surgery
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Glubran 2
Primary Outcome Measure Information:
Title
Total drainage volume
Time Frame
3 months
Title
Total seroma aspirate volume
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
3 months
Title
Duration of fluid drainage
Time Frame
3 months
Title
Time to drain removal
Time Frame
3 months
Title
Number of seroma aspirations
Time Frame
3 months
Title
Additional costs incurred due to the need of aspirations
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud AlMasri, MD
Phone
009625300460
Email
Malmasri@KHCC.JO
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Al Masri, MD
Organizational Affiliation
King Hussein Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Hussein Cancer Center
City
Amman
ZIP/Postal Code
1269 /11941
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faiez Daoud, MD
First Name & Middle Initial & Last Name & Degree
Mohammed Hamdan, MD
First Name & Middle Initial & Last Name & Degree
Mahmoud Al-Masri, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
33569343
Citation
Al-Masri M, Alawneh F, Daoud F, Ebous A, Hamdan B, Al-Najjar H, Al-Masri R, Abu Farah 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.
Results Reference
derived
Learn more about this trial
Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
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