Moran Amit1, Yoav Binenbaum, Jacob T Cohen, Ziv Gil. 1. Department of Otolaryngology Head and Neck Surgery, Rambam Medical Center, the Technion, Israel Institute of Technology, Haifa, Israel.
Abstract
BACKGROUND: This single-blinded, prospective, randomized controlled trial compared the efficacy and safety of an oxidized cellulose patch (Surgicel [Johnson and Johnson]) with conventional procedures for achieving hemostasis in thyroid surgery. STUDY DESIGN: The study included 190 patients scheduled for thyroidectomy. Patients were randomized into 1 conventionally treated (ligatures and bipolar electrocautery) group (n = 92) and a second group, which additionally received Surgicel (n = 98). RESULTS: The groups were demographically and clinically matched and had similar wound drainage volumes and mean duration of surgery. Postoperative bleeding rate was greater in the Surgicel group, yet the difference didn't reach statistical significance (p = 0.054). There were no significant group differences in postoperative wound infection, seroma, hypocalcemia, or recurrent laryngeal nerve palsy. Time to drain removal and length of hospital stay were significantly shorter in the conventional group (p < 0.001). CONCLUSIONS: Routine use of an oxidized cellulose hemostatic agent has no advantage over conventional hemostasis and is potentially harmful in thyroid surgery.
RCT Entities:
BACKGROUND: This single-blinded, prospective, randomized controlled trial compared the efficacy and safety of an oxidized cellulose patch (Surgicel [Johnson and Johnson]) with conventional procedures for achieving hemostasis in thyroid surgery. STUDY DESIGN: The study included 190 patients scheduled for thyroidectomy. Patients were randomized into 1 conventionally treated (ligatures and bipolar electrocautery) group (n = 92) and a second group, which additionally received Surgicel (n = 98). RESULTS: The groups were demographically and clinically matched and had similar wound drainage volumes and mean duration of surgery. Postoperative bleeding rate was greater in the Surgicel group, yet the difference didn't reach statistical significance (p = 0.054). There were no significant group differences in postoperative wound infection, seroma, hypocalcemia, or recurrent laryngeal nerve palsy. Time to drain removal and length of hospital stay were significantly shorter in the conventional group (p < 0.001). CONCLUSIONS: Routine use of an oxidized cellulose hemostatic agent has no advantage over conventional hemostasis and is potentially harmful in thyroid surgery.
Authors: Enver Kunduz; Erhan Aysan; Ufuk Oğuz İdiz; Yeliz Emine Ersoy; Hüseyin Kazım Bektaşoğlu; Samet Yığman; Hacer Kundakcıoğlu Journal: Turk J Surg Date: 2019-03-01