Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Se... | NCT02141373

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

NCT02141373

Sponsor

King Hussein Cancer Center

Status

Unknown status

Last Update Posted

Apr 3, 2015Estimated

Enrollment

136Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Glubran 2

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Oct 2015Estimated

Completion Date

Not provided

First Submitted Date

Apr 9, 2014

First Submission Date that Met QC Criteria

May 15, 2014

First Posted Date

May 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2015

Last Update Posted Date

Apr 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Al-Masri, Chairman, Department of Surgery, King Hussein Cancer CenterPrincipal Investigator

Lead Sponsor

King Hussein Cancer CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glubran 2	Experimental	Glubran 2 will be used at end of surgery	Device: Glubran 2
Standard Surgery	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glubran 2	Device		Glubran 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total drainage volume		3 months
Total seroma aspirate volume		3 months

Secondary Outcomes

Measure	Description	Time Frame
Adverse events		3 months
Duration of fluid drainage		3 months
Time to drain removal

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud AlMasri, MD	Contact	009625300460		Malmasri@KHCC.JO

Overall Officials

Name	Affiliation	Role
Mahmoud Al Masri, MD	King Hussein Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Hussein Cancer Center	Recruiting	Amman		1269 /11941	Jordan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33569343	Derived	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.

Type	Date	Date Unknown
Release	Feb 26, 2020
Reset	Mar 11, 2020

ID	Term
D001943	Breast Neoplasms
D049291	Seroma

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases