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Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection

Not Applicable
Conditions
Breast Cancer
Interventions
Device: Glubran 2
Registration Number
NCT02141373
Lead Sponsor
King Hussein Cancer Center
Brief Summary

Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
136
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Glubran 2Glubran 2Glubran 2 will be used at end of surgery
Primary Outcome Measures
NameTimeMethod
Total seroma aspirate volume3 months
Total drainage volume3 months
Secondary Outcome Measures
NameTimeMethod
Time to drain removal3 months
Adverse events3 months
Duration of fluid drainage3 months
Additional costs incurred due to the need of aspirations3 months
Number of seroma aspirations3 months

Trial Locations

Locations (1)

King Hussein Cancer Center

🇯🇴

Amman, Jordan

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