Incisional negative pressure wound therapy for the prevention of surgical site complications in Paediatric patients with non-idiopathic scoliosis: A randomized clinical trial.

Surgical wound complications are adverse events with important repercussions for the health of patients and health system. Surgical site infections and wound dehiscences are among the most important surgical wound complications, with a high incidence in paediatric patients undergoing surgery for non-idiopathic scoliosis. Incisional negative pressure wound therapy for surgical incisions is used as a preventive measure against surgical wound complications in adults; however, there has been scant evidence for using it in children. The purpose of this study is to evaluate the cost-effectiveness of incisional negative pressure wound therapy in preventing surgical wound complications in paediatric patients undergoing surgery to treat non-idiopathic scoliosis. Randomized clinical trial. Children younger than 18 years of age undergoing surgery for non-idiopathic scoliosis were randomly assigned into two groups to receive one of two different types of dressings for the first 7 days after surgery. One group were treated with a postoperative hydrofibre and hydrocolloid dressing with silver for wounds (control group), and the other group received a single-use incisional negative pressure wound therapy system (intervention group). The wounds were assessed after removal of the dressings at 7 days after surgery and again at 30, 90, and 180 days after surgery. Surgical wound complications, sociodemographic variables, variables related to the procedure and postoperative period, economic costs of treatment of surgical wound complications, and time to healing of the surgical wound were recorded. Per protocol and per intention to treat analysis was made. The per protocol incidence of surgical wound complications was 7.7% in the intervention group versus 38.5% in the control group (p = 0.009; Fisher exact test. RR = 0.20 IC95%: 0.05-0.83). Surgical wound dehiscence, surgical site infections, seroma, and fibrin were the most common surgical wound complications. The type of surgery, duration of surgery, and patients' age were associated with a higher risk for surgical wound complications. Postoperative hydrofibre and hydrocolloid dressing with silver for wounds were found to be associated with a longer time to healing. Initial costs for dressings in the group receiving incisional negative pressure wound therapy were higher, but the total postoperative costs were higher for those receiving postoperative hydrofibre and hydrocolloid dressing with silver for wounds. It was found that for each US$1.00 of extra costs for using incisional negative pressure wound therapy, there was a benefit of US$12.93 in relation to the cost of complications prevented. Incisional negative pressure wound therapy is cost-effective in the prevention of surgical wound complications in children undergoing surgery for non-idiopathic scoliosis.