Evaluating the Need for Post-Operative Antibiotics After Surgery for Mandible Fractures in Adults The MANTRA Trial

What this Trial Is About

Researchers are evaluating whether post-operative antibiotics are necessary following surgery for patients with mandible fractures. This trial, known as the MANTRA trial, aims to determine if giving no antibiotics or different antibiotic regimens after surgery is as effective as the current common practice. The study addresses the concern of antibiotic overuse and resistance, as mandible fractures are common and often require surgery with titanium miniplates, which may risk infection. The trial compares three groups one receiving no further antibiotics after a single intravenous dose at surgery induction, another receiving two additional postoperative intravenous doses, and a third receiving two postoperative intravenous doses followed by a five-day course of oral antibiotics. All participants receive one dose of intravenous co-amoxiclav before surgery. This randomized, open-label, multicenter study will include an internal pilot phase to optimize recruitment and retention. Participants will be monitored for surgical site infections and other outcomes such as return to surgery, hospital stay length, complications, and quality of life up to 180 days after surgery. The study includes assessments of antibiotic exposure and cost-effectiveness. Data will be collected through hospital records and follow-ups, with a total trial duration extending through recruitment, treatment, and follow-up phases until the end of 2027.

The MANTRA Trial (MANdibular TRauma and Antibiotic Use)