NCT00909649

Brief Summary

This study was carried out from January 2005 to December 2007 at Mansoura university hospital. Fifty patients who had breast cancer were included in the study, MRM was done for all patients. Patients were randomly divided into two groups. Group І with fibrin glue 4ml of fibrin glue was sprayed on the surgical area with Y canula and group П without fibrin glue. Preoperative, Operative and Postoperative data were collected including postoperative measurement of drainage, date of removal of the drain, state of the wound, incidence of Seroma formation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 28, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

May 28, 2009

Completed
Last Updated

May 28, 2009

Status Verified

April 1, 2009

Enrollment Period

2.4 years

First QC Date

December 5, 2008

Results QC Date

December 5, 2008

Last Update Submit

May 27, 2009

Conditions

Breast Cancer

Keywords

fibrin glueseromamastectomy

Outcome Measures

Primary Outcomes (1)

  • Seroma Formation

    the mean total drainage volume

    within 30 days postoperative

Study Arms (2)

1 fibrin glue

ACTIVE COMPARATOR

8 ml of fibrin glue was sprayed on the surgical area with Y canula ( doubleject application system).One milliliter of fibrin glue contains 70-100 mg. fibrinogen, 10-50 u factor 8 aprotinin 3000k iu/ml, 2-9 mg fibronectin,40-120 ug plasminogen ,4 Iu/ml thrombin, 40 mmol cocl2/L (immuno AG/austrial)

Procedure: fibrin glue in breast surgery

2 non fibrin glue

NO INTERVENTION

after good haemostasis the same sized drain was applied in axillary and breast area and incision was closed. Followed by external compression for 10 minutes in both groups. Drains were left in places until the drainage for the preceding 24 h was less than 20 ml.

Interventions

fibrin glue in breast surgeryPROCEDURE

fibrin glue 8 ml in the bed after modified radical mastectomy in fibrin treated group

Also known as: fibrin glue after modifed radical mastectomy
1 fibrin glue

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with operable breast cancer

You may not qualify if:

  • Patients who received preoperative chemotherapy and radiotherapy were exclude
  • Patients with previous axillary surgery
  • Patients who underwent simultaneous reconstructive surgery and breast conservative surgery
  • Locally advanced breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ayman Elnakeeb

Mansoura , Egypt, Mansoura,egypt, 050, Egypt

Location

Ayman Elnakeeb

Al Mansurah, Mansoura, 050, Egypt

Location

Related Publications (2)

  • Ulusoy AN, Polat C, Alvur M, Kandemir B, Bulut F. Effect of fibrin glue on lymphatic drainage and on drain removal time after modified radical mastectomy: a prospective randomized study. Breast J. 2003 Sep-Oct;9(5):393-6. doi: 10.1046/j.1524-4741.2003.09506.x.

    PMID: 12968960BACKGROUND

  • Johnson L, Cusick TE, Helmer SD, Osland JS. Influence of fibrin glue on seroma formation after breast surgery. Am J Surg. 2005 Mar;189(3):319-23. doi: 10.1016/j.amjsurg.2005.01.004.

    PMID: 15792759RESULT

MeSH Terms

Conditions

Breast NeoplasmsSeroma

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Elnakeeb Ayman
Organization
Mansoura university hospital
elnakeebayman@yahoo.com
0106752021

Study Officials

  • ayman elnakeeb

    Mansoura University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2008

First Posted

May 28, 2009

Study Start

January 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

May 28, 2009

Results First Posted

May 28, 2009

Record last verified: 2009-04

Locations

EG(2)