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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02141373
• Other study ID #: PRT-CTU-0912/03 Version 5.0
• Status: Recruiting
• Phase: N/A
• First received: April 9, 2014
• Last updated: April 2, 2015
• Start date: October 2013

Study information

• Verified date: April 2015
• Source: King Hussein Cancer Center
• Contact: Mahmoud AlMasri, MD
• Phone: 009625300460
• Email: Malmasri[@]KHCC.JO
• Is FDA regulated: No
• Health authority: Jordan: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Glubran 2

Locations

Country	Name	City	State
Jordan	King Hussein Cancer Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
King Hussein Cancer Center

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total drainage volume		3 months	No
Primary	Total seroma aspirate volume		3 months	No
Secondary	Adverse events		3 months	Yes
Secondary	Duration of fluid drainage		3 months	No
Secondary	Time to drain removal		3 months	No
Secondary	Number of seroma aspirations		3 months	No
Secondary	Additional costs incurred due to the need of aspirations		3 months	No