Influence of Fibrin Glue on Seroma Formation After Modified Radical Mastectomy

NCT ID: NCT00909649

Last Updated: 2009-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-06-30

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.

Conditions

Breast Cancer

Keywords

fibrin glue; seroma; mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

fibrin glue in breast surgery

Intervention Type: PROCEDURE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

fibrin glue in breast surgery

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

Intervention Type: PROCEDURE

Other Intervention Names

fibrin glue after modifed radical mastectomy

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

mansoura university,egypt

Principal Investigators

ayman elnakeeb

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Ayman Elnakeeb

Mansoura , Egypt, Mansoura,egypt, Egypt

Ayman Elnakeeb

Al Mansurah, Mansoura, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 12968960 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15792759 (View on PubMed)

Other Identifiers

seroma in breast surgery

Identifier Type: -

Identifier Source: org_study_id