Breast Cancer
Conditions
Keywords
seroma, axillary, dissection
Brief summary
Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.
Interventions
DEVICEGlubran 2
Sponsors
King Hussein Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total drainage volume | 3 months |
| Total seroma aspirate volume | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to drain removal | 3 months |
| Adverse events | 3 months |
| Additional costs incurred due to the need of aspirations | 3 months |
| Number of seroma aspirations | 3 months |
| Duration of fluid drainage | 3 months |
Countries
Jordan
Contacts
Primary ContactMahmoud AlMasri, MD
Outcome results
None listed