Prospective trial of efficiency and safety of fibrin sealant criofit after autologous breast reconstruction in stages I–III breast cancer

Introduction. Breast cancer is the most common cancer. Success in early diagnostic and system treatment is achieved. All the same mastectomy with reconstruction is the best option for some patients. Seroma is common complication after reconstructive plastic surgery.
Aim. To analyze efficiency of using fibrin sealant criofit at donor zone after autologous breast reconstruction in decreasing seroma incidences.
Materials and methods. This is randomised controlled clinical trial of fibrin sealant criofit effect on assessing of seroma incidences, timing of drain removal at donor zone after autologous breast reconstruction in comparison with control group. Surgical technic, drains removal criteria and patients characteristics were identical in both groups.
Results. Average drain fluid volume on the first day (150.9 ± 40.7 ml vs 190.6 ± 60.7 ml; p <0.001) and second day (152.6 ± 53.3 ml vs 184.9 ± 90.3 ml; p = 0.04) after surgery was significantly lower in experimental group. Average number of days of drainage in criofit group was significantly lower (6.3 ± 1.1 days vs 7.4 ± 2.1 days; p = 0.01). Seroma incidences in experimental group was lower in comparison with control group (10 % vs 23 %). It was statistically significant.
Conclusion. We aimed to asses the efficiency of fibrin sealant criofit at donor zone after autologous breast reconstruction. Criofit decrese the volume of serous draining in first days after surgery, number of days of drainage and seroma incidences significantly. But more powerful clinical trials are needed. Study limitations are small sample, changes in surgery team, small observation period.