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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00909649
First received: December 5, 2008
Last updated: May 27, 2009
Last verified: April 2009
  Purpose

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 Intervention
Breast Cancer
Procedure: fibrin glue in breast surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Influence of Fibrin Glue on Seroma Formation After Modified Radical

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Seroma Formation [ Time Frame: within 30 days postoperative ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: January 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: mansoura university hospital, mansoura university,egypt
ClinicalTrials.gov Identifier: NCT00909649     History of Changes
Other Study ID Numbers: seroma in breast surgery
Study First Received: December 5, 2008
Results First Received: December 5, 2008
Last Updated: May 27, 2009
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
fibrin glue
seroma
mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Fibrin Tissue Adhesive
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014