This research was a randomized controlled trial that was carried out at the surgery departments of Suez Canal college Hospital from July 2017 to December 2018. The study was reviewed by our research ethics committee in the Faculty of Medicine of Suez Canal University at its meeting on 11/6/2017. The study adhered to CONSORT guideline.
In the current work, sixty consecutive patients who were diagnosed with breast cancer and treated by MRM were recruited.
Newly diagnosed breast cancer stage I or II, who had no previous surgery on the axillary lymphatic system on the same side, no previous radiotherapy, nor corticosteroid treatment were included (Flow chart).
Autologous Fibrin Glue preparation
The fibrin glue was prepared at Suez Canal University Hospital blood bank. All recruited patients were eligible for autologous blood donation. Three days prior to surgery, approximately 450 mL were obtained in triple blood bags containing 70 mL CPDA-1 (purchased from JMS, Singapore). The plasma was separated from the red blood cells within 2 hours by centrifugation (Centrifuge: Thermo Sorvall™ RC 12BP, Thermo Fisher Scientific, USA) at 2200 x g for 10 minutes. The plasma was frozen and stored for 48 hours at -40° C. Then, fresh frozen plasma was thawed at 4° C for 8 hours before centrifugation at 2200 x g for 10 minutes and the supernatant plasma was transported to the other satellite bag. The cryoprecipitate was suspended in 15 ml of plasma. Seven millilitres of fibrinogen and factor XIII (which is a fibrin stabilizing factor) containing precipitate were drawn into a syringe.
An hour before the operation. We used autologous thrombin obtained by drawing 14 ml of blood from the patient in plain tubes, which were left 30 minutes until clotting occurred and then centrifuged at 1000 x g for 12 minutes; then the supernatant was collected (About 7 ml), which represents autologous thrombin . Then, we added the cryoprecipitate in equal volume to the thrombin. Finally, we added 2 ml calcium gluconate (50 mg/mL calcium gluconate monohydrate) just before 2 minutes of application into the flaps.
The patients were randomly allocated to either the intervention or control group. Once the patient consented to enter the trial, each patient was randomly assigned using sealed white envelopes. Patients were equally allocated at a ratio of 1:1 to either the intervention or control group.
All patients underwent MRM. The same technique was followed in both groups; the use of electrocautery was minimized as much as possible, and meticulous haemostasis was performed. After mastectomy, the intervention cases received fibrin glue plus drain insertion before wound closure. The prepared glue mixture was sprayed after the field had dried completely; 8 ml were applied to the dead space under the skin flaps, and the other 8 ml were applied to the axillary bed. (Fig. 1)
After spraying the mixture, we exerted gentle pressure for at least 5 minutes over the flaps and axilla and then closed the wound in layers as rapidly as possible. Last, we placed a small compressing cotton pad in the axilla. In the control group, we performed MRM using the same technique with meticulous haemostasis but closed the flaps immediately after inserting the drains (In both groups, we inserted two separate suction drains one at the axilla, and the other under skin flaps).
In both groups, we removed the drains once the volume of drained fluid was less than or equal to 30 cm3 per day, for 3 successive days.
The major factor assessed in the trial was the amount of drained fluid in the postoperative period; the secondary outcome was the duration took to remove the drain. In addition, we recorded the number of excised lymph nodes and the pathology results.
The gathered information were examined using IBM Statistical Package for Social Sciences software (SPSS), 21st edition. Continuous data were expressed as mean ± standard deviation and categorical data as frequencies and percentages. When data were tested for normality, they were not normally distributed, therefore, Mann Whiney U test and Kruskal Wallis test were used to compare continuous variables between different groups. Fisher's exact test and chi-square test were used for statistical analysis of categorical variables. Time-to-drain removal was analysed with survival analysis. Survival function was presented as Kaplan Meier curve, while the log rank test was used to test for the statistical significance of the difference in survival distribution between the intervention group and its control. For all tests a probability value of less than 0.05 was considered statistically significant.