Rikke F Vestergaard1, Per H Nielsen2, Kim A Terp2, Kjeld Søballe3, Gratien Andersen4, John M Hasenkam5. 1. Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark; Department of Orthopedics, Aarhus University Hospital, Aarhus, Denmark. Electronic address: rikke.vestergaard@ki.au.dk. 2. Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark. 3. Department of Orthopedics, Aarhus University Hospital, Aarhus, Denmark. 4. Department of Radiology, Aarhus University Hospital, Aarhus, Denmark. 5. Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.
Abstract
BACKGROUND: Postoperative sternal infection and dehiscence cause increased morbidity, mortality, and socioeconomic costs as well as patient discomfort and pain. Some predisposing factors have been uncovered but others remain uninvestigated. Among these are the influence of topical hemostatic agents such as bone wax (BW) and Ostene (Ceremed Inc, Los Angeles, CA) a new, water-soluble polymer wax (WSW). The object of this study was to investigate the impact of topical hemostatic agents on sternal healing in patients. METHODS: In total, 50 patients subjected to elective cardiac surgery and requiring intraoperative hemostatic treatment were randomized to 1 of 2 treatment groups: BW or WSW. Twenty-five patients without need for sternal hemostasis constituted a control group. The doctors analyzing the endpoints were blinded to the treatment. Radiologic bone healing was assessed by a radiologist using computed tomography at 3 and 6 months postoperatively. Quality of life and bodily pain was assessed by questionnaires (Short Form-36 and Visual Analogue Scale). RESULTS: No patients displayed complete radiologic healing at 3 months. Bone healing (evaluated semi-quantitatively at a score from 0 to 10) was significantly impaired in the BW group compared with both the control and WSW groups at both 3 and 6 months postoperatively (p < 0.0001). Radiologic bone healing was positively correlated with physical functioning score (Short Form-36) (p < 0.001). Pain scores were generally low (<1) at both 3 and 6 months with no significant difference between study groups. CONCLUSIONS: The results from this study suggest that WSW provides a useful alternative to BW when topic hemostasis on the sternum is required.
RCT Entities:
BACKGROUND: Postoperative sternal infection and dehiscence cause increased morbidity, mortality, and socioeconomic costs as well as patient discomfort and pain. Some predisposing factors have been uncovered but others remain uninvestigated. Among these are the influence of topical hemostatic agents such as bone wax (BW) and Ostene (Ceremed Inc, Los Angeles, CA) a new, water-soluble polymer wax (WSW). The object of this study was to investigate the impact of topical hemostatic agents on sternal healing in patients. METHODS: In total, 50 patients subjected to elective cardiac surgery and requiring intraoperative hemostatic treatment were randomized to 1 of 2 treatment groups: BW or WSW. Twenty-five patients without need for sternal hemostasis constituted a control group. The doctors analyzing the endpoints were blinded to the treatment. Radiologic bone healing was assessed by a radiologist using computed tomography at 3 and 6 months postoperatively. Quality of life and bodily pain was assessed by questionnaires (Short Form-36 and Visual Analogue Scale). RESULTS: No patients displayed complete radiologic healing at 3 months. Bone healing (evaluated semi-quantitatively at a score from 0 to 10) was significantly impaired in the BW group compared with both the control and WSW groups at both 3 and 6 months postoperatively (p < 0.0001). Radiologic bone healing was positively correlated with physical functioning score (Short Form-36) (p < 0.001). Pain scores were generally low (<1) at both 3 and 6 months with no significant difference between study groups. CONCLUSIONS: The results from this study suggest that WSW provides a useful alternative to BW when topic hemostasis on the sternum is required.
Authors: Mohammad Abd Alkhalik Basha; Dina Said Shemais; Essam Saad Abdelwahed; Rabab Mahmoud Elfwakhry; Ayman Fathy Zeid; Ahmed A El-Hamid M Abdalla; Sameh Abdelaziz Aly; Dalia Said Abdelrahman; Anwar A Elshenawy; Waleed Mansour; Khaled Ahmed Ahmed Elbanna; Mohammad El Tahlawi; Nezar Elnahal Journal: Int J Gen Med Date: 2021-12-02