Use of fibrin glue in groin wound closure after femoral artery exposure: randomized controlled trial

Abstract

Objectives Fibrin glue is supposed to seal tissues, lymphatics, and minor bleeders and close the dead space efficiently. This work was designed to show the effect of fibrin glue on groin wound complications after femoral artery exposure, degree of wound infection, time to wound healing, and need for further patient management. Patients and methods It is a prospective randomized controlled study including patients who were submitted to groin incision for femoral artery exposure; patients were randomized into two groups: fibrin-sealant closure group (FS group) or conventional surgery (CS group). FS group patients were submitted to use of fibrin glue sprayed on the femoral sheath before closure of subcutaneous tissue and CS group patients were submitted to conventional surgical closure. The study was conducted from July 2016 to March 2018. The primary outcome was assigned as wound complications like seroma, lymphatic fistula, lymphorrhea, and wound infection. The secondary outcomes were wound-healing time, hospital stay, and need for operative coverage. Results In total, 119 patients were included in the study, 60 in fibrin glue group (10 were lost from follow-up) and 59 conventional surgical closure (nine were lost from follow-up). The mean age was 54.95±3.5 in FS group compared with 60.20±3.7 in CS group (P=0.31). In FS group, 33 were males and 27 were females, while in CS group, 38 were males and 21 were males (P=0.42). Mean BMI was 30.3±0.68 in FS group and 28.63±0.84 in CS group (P=0.42). In FS group, 36 were diabetics versus 30 patients in CS group (P=0.53). In total, 33 patients were hypertensive in FS group versus 30 patients in CS group (P=0.10). In total, six patients were end-stage renal disease in both groups. In total, 30 patients were smokers in FS group versus 32 patients in CS group (P=0.75). The mean follow-up time till ensuring wound healing was 22 days, while the median was 27 days. Wound seroma/lymphorrhea was observed in 12 patients of FS group and 30 patients of CS group (P=0.06). Wound infection developed in 10 patients in the FS group and 17 patients in CS group (P=0.48). Regarding grade-III wound infection, no patient belonged to FS group, while eight patients belonged to CS group; as regards hospital stay, duration/day was 6.15±0.35 in FS group and 10.20±1.2 in CS group (P=0.005), time to wound healing was 15.05 ±10.95 in FS group and 28.40 ±20.85 in CS group (P=0.015), and no patient needed further surgical wound coverage in CS group but seven patients did in CS group. Conclusion Application of FS before groin-wound closure seems to be of benefit to reduce wound complications like degree of infection, accelerate time to wound healing, and need for further surgical coverage and hospital stay.