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

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ClinicalTrials.gov Identifier: NCT00909649
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : May 28, 2009
Last Update Posted : May 28, 2009
Sponsor:
Information provided by:
Mansoura University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: fibrin glue in breast surgery Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Influence of Fibrin Glue on Seroma Formation After Modified Radical
Study Start Date : January 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 fibrin glue
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
fibrin glue 8 ml in the bed after modified radical mastectomy in fibrin treated group
Other Name: fibrin glue after modifed radical mastectomy
No Intervention: 2 non fibrin glue
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.



Primary Outcome Measures :
  1. Seroma Formation [ Time Frame: within 30 days postoperative ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT00909649


Locations
Egypt
Ayman Elnakeeb
Mansoura , Egypt, Mansoura,egypt, Egypt, 050
Ayman Elnakeeb
Mansoura, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: ayman elnakeeb Mansoura University Hospital

Publications of Results:
Other Publications:
Responsible Party: mansoura university hospital, mansoura university,egypt
ClinicalTrials.gov Identifier: NCT00909649     History of Changes
Other Study ID Numbers: seroma in breast surgery
First Posted: May 28, 2009    Key Record Dates
Results First Posted: May 28, 2009
Last Update Posted: May 28, 2009
Last Verified: April 2009

Keywords provided by Mansoura University:
fibrin glue
seroma
mastectomy

Additional relevant MeSH terms:
Seroma
Inflammation
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants