Trial Information

Influence of Fibrin Glue on Seroma Formation After Modified Radical

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.