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

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ClinicalTrials.gov Identifier: NCT02141373
Recruitment Status : Unknown
Verified April 2015 by Mahmoud Al-Masri, King Hussein Cancer Center.
Recruitment status was:  Recruiting
First Posted : May 19, 2014
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Mahmoud Al-Masri, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Glubran 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Glubran 2
Glubran 2 will be used at end of surgery
Device: Glubran 2
No Intervention: Standard Surgery



Primary Outcome Measures :
  1. Total drainage volume [ Time Frame: 3 months ]
  2. Total seroma aspirate volume [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 3 months ]
  2. Duration of fluid drainage [ Time Frame: 3 months ]
  3. Time to drain removal [ Time Frame: 3 months ]
  4. Number of seroma aspirations [ Time Frame: 3 months ]
  5. Additional costs incurred due to the need of aspirations [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141373


Contacts
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Contact: Mahmoud AlMasri, MD 009625300460 Malmasri@KHCC.JO

Locations
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Jordan
King Hussein Cancer Center Recruiting
Amman, Jordan, 1269 /11941
Sub-Investigator: Faiez Daoud, MD         
Sub-Investigator: Mohammed Hamdan, MD         
Principal Investigator: Mahmoud Al-Masri, MD         
Sponsors and Collaborators
King Hussein Cancer Center
Investigators
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Principal Investigator: Mahmoud Al Masri, MD King Hussein Cancer Center

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Responsible Party: Mahmoud Al-Masri, Chairman, Department of Surgery, King Hussein Cancer Center
ClinicalTrials.gov Identifier: NCT02141373     History of Changes
Other Study ID Numbers: PRT-CTU-0912/03 Version 5.0
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Mahmoud Al-Masri, King Hussein Cancer Center:
seroma
axillary
dissection

Additional relevant MeSH terms:
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Breast Neoplasms
Seroma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Inflammation
Pathologic Processes