Subdermal Application of 10% Povidone-Iodine to Reduce Bacterial Contamination During Posterior Spinal Fusion Surgery for Scoliosis

What this Trial Is About

Researchers are investigating the use of 10% povidone-iodine applied beneath the skin to reduce bacterial contamination during posterior spinal fusion surgeries in patients with spinal fusion. This Phase 4 randomized controlled trial aims to compare the presence of bacteria in different layers of the surgical wound between patients treated with povidone-iodine and those treated with saline. The study also monitors complications such as allergic reactions, contact dermatitis, surgical site infections, and wound healing issues. Participants will be randomly assigned to one of two groups: one receiving three applications of 10% povidone-iodine in the subdermal layer after the initial incision, and the other receiving three applications of sterile saline in the same manner. Both groups will follow a standard surgical protocol including antibiotics, skin preparation with isopropyl alcohol, ChloraPrepTM, and sterile draping. Bacterial cultures will be taken at five different points during the surgery to assess bacterial growth. Throughout the study, patients will be monitored for bacterial contamination and any complications for up to one year post-operation. Researchers will collect bacterial samples during surgery and track patient outcomes while keeping the surgical team blinded to culture results. Routine postoperative care will continue as usual, and a data safety monitor will oversee the correlation between bacterial cultures and infection rates to ensure patient safety during the study.

Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion