BACKGROUND: This study was designed to determine the effectiveness of Hemaseel APR fibrin sealant versus conventional drain placement in the prevention of seromas after breast procedures. METHODS: A prospective, randomized, controlled study of subjects who were randomized intocontrol (drain) and experimental (fibrin) groups was conducted. RESULTS: Analysis of 82 patients showed similarly matched groups. Seroma formation rate was 45.5% in the control group and 36.8% in the fibrin glue group (P = 0.43). The rate of wound complications was similar. Aspirate volumes were significantly greater in the fibrin glue group. Drain placement saved patients >366 US dollars over fibrin glue. CONCLUSIONS: Although use of fibrin sealant resulted in a nonsignificant decrease in seroma formation rate compared with that of drain placement, the higher cost involved, cumbersome technique, and higher aspirate volumes tend to indicate that there is no advantage to using fibrin glue over drain placement with the technique described.
RCT Entities:
BACKGROUND: This study was designed to determine the effectiveness of Hemaseel APR fibrin sealant versus conventional drain placement in the prevention of seromas after breast procedures. METHODS: A prospective, randomized, controlled study of subjects who were randomized into control (drain) and experimental (fibrin) groups was conducted. RESULTS: Analysis of 82 patients showed similarly matched groups. Seroma formation rate was 45.5% in the control group and 36.8% in the fibrin glue group (P = 0.43). The rate of wound complications was similar. Aspirate volumes were significantly greater in the fibrin glue group. Drain placement saved patients >366 US dollars over fibrin glue. CONCLUSIONS: Although use of fibrin sealant resulted in a nonsignificant decrease in seroma formation rate compared with that of drain placement, the higher cost involved, cumbersome technique, and higher aspirate volumes tend to indicate that there is no advantage to using fibrin glue over drain placement with the technique described.
Authors: Yuhan Lee; Chenjie Xu; Monisha Sebastin; Albert Lee; Nathan Holwell; Calvin Xu; David Miranda Nieves; Luye Mu; Robert S Langer; Charles Lin; Jeffrey M Karp Journal: Adv Healthc Mater Date: 2015-07-27 Impact factor: 9.933