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Influence of Fibrin Glue on Seroma Formation After Modified Radical Mastectomy (MRM)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fibrin glue in breast surgery
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring fibrin glue, seroma, mastectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with operable breast cancer

Exclusion Criteria:

  • 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

Sites / Locations

  • Ayman Elnakeeb
  • Ayman Elnakeeb

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1 fibrin glue

2 non fibrin glue

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Seroma Formation
the mean total drainage volume

Secondary Outcome Measures

Full Information

First Posted
December 5, 2008
Last Updated
May 27, 2009
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT00909649
Brief Title
Influence of Fibrin Glue on Seroma Formation After Modified Radical Mastectomy
Acronym
MRM
Official Title
Influence of Fibrin Glue on Seroma Formation After Modified Radical
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study was carried out from January 2005 to December 2007 at Mansoura university hospital, Departement 8 of surgical department. This study approved by local ethical committee Fifty patients had breast cancer were included in the study. Patients who received preoperative chemotherapy and radiotherapy were exclude Also, patients with previous axillary surgery or patients who underwent simultaneous reconstructive surgery and breast conservative surgery and locally advanced breast cancer were exclude. Informed written consent was obtained from all patients included in the study. All patients include in the study, MRM was done for then and axillary lymphadenectomy extended to the axillary level III was done with sharp dissection and ligation of the visible lymph vessels and minor blood vessel. After performing hemostasis in the mastectomy and axillary area. .Patients were randomly divided by closed envelop into two groups. Patients were randomized at end of surgical procedure to avoid possible treatment bias during surgical procedure. Group І (with fibrin glue) and group П without fibrin glue. In fibrin glue group. 4 ml of fibrin glue was sprayed on the surgical area with Y canula (doubleject application system). In group 11 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 30 ml/day. Data collected Preoperative data collected included age, body mass indexed (BMI), medical and surgical history, history of chemotherapy, radiotherapy Operative data included estimated blood loss, types of dissection, duration of the operation Postoperative data included hospital stay , postoperative measurement of drainage daily , date of removal , state of the wound ( infection , haematoma, necrosis , opened wound ), number of axillary lymph nodes dissected , cancer stage , number of axillary lymph nodes positive, incidence of Seroma formation , interval of Seroma resolution , Seroma aspirated volume and number of postoperative visits Seroma formation was defined as inability to remove participant drain by postoperative day 10 because of high output (more than 30 ml /day drain Seroma) and / or the need to aspirate of fluid after removal of the drain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
fibrin glue, seroma, mastectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 fibrin glue
Arm Type
Active Comparator
Arm Description
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)
Arm Title
2 non fibrin glue
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
fibrin glue in breast surgery
Other Intervention Name(s)
fibrin glue after modifed radical mastectomy
Intervention Description
fibrin glue 8 ml in the bed after modified radical mastectomy in fibrin treated group
Primary Outcome Measure Information:
Title
Seroma Formation
Description
the mean total drainage volume
Time Frame
within 30 days postoperative

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with operable breast cancer Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayman elnakeeb
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman Elnakeeb
City
Mansoura , Egypt
State/Province
Mansoura,egypt
ZIP/Postal Code
050
Country
Egypt
Facility Name
Ayman Elnakeeb
City
Mansoura
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
12968960
Citation
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.
Results Reference
background
PubMed Identifier
15792759
Citation
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.
Results Reference
result

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Influence of Fibrin Glue on Seroma Formation After Modified Radical Mastectomy

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