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

NCT ID: NCT02141373

Last Updated: 2015-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Glubran 2

Glubran 2 will be used at end of surgery

Group Type EXPERIMENTAL

Glubran 2

Intervention Type DEVICE

Standard Surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Glubran 2

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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King Hussein Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Al-Masri

Chairman, Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Al Masri, MD

Role: PRINCIPAL_INVESTIGATOR

King Hussein Cancer Center

Locations

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King Hussein Cancer Center

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Mahmoud AlMasri, MD

Role: CONTACT

009625300460

References

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Al-Masri M, Alawneh F, Daoud F, Ebous A, Hamdan B, Al-Najjar H, Al-Masri R, Abufara M. Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial. Front Oncol. 2021 Jan 25;10:580861. doi: 10.3389/fonc.2020.580861. eCollection 2020.

Reference Type DERIVED
PMID: 33569343 (View on PubMed)

Other Identifiers

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PRT-CTU-0912/03 Version 5.0

Identifier Type: -

Identifier Source: org_study_id

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