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

King Hussein Cancer Center

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: Glubran 2

Study type: Interventional

Funder types: Other

Identifiers

NCT02141373

PRT-CTU-0912/03 Version 5.0

Details and patient eligibility

About

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

Enrollment: 136 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

136 participants in 2 patient groups

Glubran 2

Experimental group

Description:

Glubran 2 will be used at end of surgery

Treatment:

Device: Glubran 2

Standard Surgery

No Intervention group