Efficacy and safety of a novel absorbable bone wax as a hemostatic agent for periacetabular osteotomy: a prospective, randomized controlled trial

BACKGROUND: Periacetabular osteotomy (PAO) is a widely used procedure to treat developmental dysplasia of the hip (DDH) in adults. Traditional bone wax cannot be absorbed on the osteotomy surface when bleeding ceases. This study aimed to evaluate the hemostatic efficacy and safety of a novel absorbable bone wax for PAO. METHODS: In this prospective, randomized, single-blinded, parallel, positive-controlled clinical trial, 70 patients with DDH treated by PAO were enrolled between October 2020 and October 2022. During the operation, the novel absorbable bone wax or the conventional bone wax was used to stanch blood exudation from the osteotomy surface randomly. The primary outcome was hemostasis time. The secondary outcomes included osteotomy surface healing time, blood parameters, and absorbability of the novel bone wax. A 2-year follow-up of the enrolled patients was then conducted. RESULTS: The follow-up results revealed that the hemostasis time was not significantly different between the two groups (P > 0.05). Moreover, no statistically significant differences were observed between the two groups in blood parameters tests at 3 days or 2 weeks post-surgery (P > 0.05). Telephone follow-ups at 2 and 6 weeks post-surgery identified no patients with poor wound healing or other adverse effects. Postoperative imaging demonstrated absorbability of the novel bone wax and bone healing of the pubic osteotomy. CONCLUSIONS: Absorbable bone wax which is a novel type of bone wax material, is safe and reliable for the hemostasis of osteotomy surfaces in the human body. The results support the clinical application and popularization of this novel absorbable bone wax in surgical procedures. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2000033242). Registered 25/05/2020.