Breast Cancer
Conditions
Keywords
fibrin glue, seroma, mastectomy
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.
Interventions
fibrin glue 8 ml in the bed after modified radical mastectomy in fibrin treated group
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroma Formation | within 30 days postoperative | the mean total drainage volume |
Countries
Egypt
Participant flow
Recruitment details
medical clinic
Participants by arm
| Arm | Count |
|---|---|
| Fibrin Group | 25 |
| Non Fibrin Group | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Non Fibrin Group | Fibrin Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6.0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 44.0 Participants |
| Age Continuous | 51.6 years STANDARD_DEVIATION 10.8 | 52.2 years STANDARD_DEVIATION 11.5 | 51.9 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Egypt | 25 participants | 25 participants | 50.0 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50.0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0.0 Participants |
Outcome results
Seroma Formation
the mean total drainage volume
Time frame: within 30 days postoperative
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibrin Group | Seroma Formation | 770.48 ml | Standard Deviation 70.81 |
| Non Fibrin Group | Seroma Formation | 1089.51 ml | Standard Deviation 75.8 |