Belisario Dominguez

Researchers are evaluating the effects of pre-operative chlorhexidine mouthwash and perioperative oxygen levels on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This Phase 3, multi-center, randomized controlled trial is conducted across hospitals in low and middle-income countries, focusing on adults and children aged 10 years or older having elective or emergency midline laparotomy. The study aims to reduce serious postoperative complications that significantly contribute to mortality and healthcare burden, especially in these resource-limited settings. Participants will be randomly assigned to one of four groups combining the use or non-use of chlorhexidine mouthwash before surgery and different oxygen concentrations during surgery: (a) mouthwash with high oxygen (80-100% FiO2), (b) no mouthwash with high oxygen, (c) mouthwash with low oxygen (21-30% FiO2), or (d) no mouthwash with low oxygen. The trial includes a 6-month internal pilot phase to assess recruitment and compliance, followed by a main phase enrolling approximately 12,924 participants. During the study, researchers will monitor participants for pneumonia and surgical site infections within 30 days after surgery using CDC definitions. Data on treatment adherence and participant outcomes will be collected and assessed by blinded outcome assessors. The study will track complications and follow patients through their recovery to evaluate how these interventions might reduce postoperative infections and improve surgical outcomes.