Breast CancerNCT02141373
Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
A study testing Glubran 2 in people with Breast Cancer, run by King Hussein Cancer Center at 1 site in Jordan.
Trial summary
Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Glubran 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteJordan
- Study dates
- Oct 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
King Hussein Cancer Center
Amman, 1269 /11941
Faiez Daoud, MD
Mohammed Hamdan, MD
About this study
Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Glubran 2
- Keywords
- seroma, axillary, dissection
- Medical subject headings
- Breast Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glubran 2Device
| Study group | Role | What they receive |
|---|---|---|
| Glubran 2 | Experimental | Glubran 2 will be used at end of surgery Receives: Device: Glubran 2 |
| Standard Surgery | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total drainage volume
Measured: 3 months
Total seroma aspirate volume
Measured: 3 months
Secondary outcomes (5)
Adverse events
Measured: 3 months
Duration of fluid drainage
Measured: 3 months
Time to drain removal
Measured: 3 months
Number of seroma aspirations
Measured: 3 months
Additional costs incurred due to the need of aspirations
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Al-Masri, King Hussein Cancer Center
- Investigators
- Mahmoud Al Masri, MD, Principal investigator, King Hussein Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141373
- Sponsor's protocol ID
- PRT-CTU-0912/03 Version 5.0
- Status last verified
- Apr 2015
- First submitted
- 9 Apr 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33569343
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
- ClinicalTrials.gov ID
- NCT02141373
- Acronym / sponsor ID
- PRT-CTU-0912/03 Version 5.0
- Conditions
- Breast Cancer
- Keywords
- seroma, axillary, dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glubran 2 | Experimental | Device: Glubran 2Glubran 2 will be used at end of surgery |
| Standard Surgery | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glubran 2 | Device | Glubran 2 |
Primary outcome
Total drainage volume
Time frame: 3 months
Total seroma aspirate volume
Time frame: 3 months
5 secondary outcomes
Adverse events
Time frame: 3 months
Duration of fluid drainage
Time frame: 3 months
Time to drain removal
Time frame: 3 months
Number of seroma aspirations
Time frame: 3 months
Additional costs incurred due to the need of aspirations
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 33569343Al-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Al Masri, MD principal investigator
King Hussein Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glubran 2 in people with Breast Cancer, run by King Hussein Cancer Center at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud AlMasri, MD (009625300460, Malmasri@KHCC.JO), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total drainage volume (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02141373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.