Clinical trial NCT00909649: Influence of Fibrin Glue on Seroma Formation After Modified Radical Mastectomy
Official title: Influence of Fibrin Glue on Seroma Formation After Modified Radical
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: fibrin glue
seroma
mastectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2009-05-28
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Seroma Formation
timeFrame: within 30 days postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura , Egypt
country: Egypt
facility: Ayman Elnakeeb
state: Mansoura,egypt
city: Mansoura
country: Egypt
facility: Ayman Elnakeeb
Study officials:
affiliation: Mansoura University Hospital
name: ayman elnakeeb
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.