Randomised controlled trial comparing antibiotic cement bead pouch versus negative pressure wound therapy for the management of severe open tibia fracture wounds: Beads versus VAC (BvV) protocol

INTRODUCTION: Early open fracture management aims to minimise the risk of complications. For the most severe open fracture wounds, multiple irrigation and debridement surgeries are required to overcome severe wound contamination, to reassess the evolving tissue injury or to temporise and plan further surgery. When multiple irrigation and debridement surgeries are needed, uncertainty remains about how the open fracture wound should be managed to best minimise complications. The primary aim of this trial is to compare the antibiotic cement bead pouch vs negative pressure wound therapy in the management of patients with severe open tibia fracture wounds. METHODS AND ANALYSIS: BvV is a multicentre, pragmatic, parallel arm randomised controlled trial that aims to enrol 312 adult patients admitted to a participating centre with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Participants will be randomly allocated on a 1:1 basis to either antibiotic cement bead pouch or negative pressure wound therapy. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomisation. Using the win ratio approach, we will hierarchically assess the composite outcome in the following order: (i) all-cause mortality, (ii) injury-related amputation of the lower extremity, (iii) unplanned reoperation to manage wound complications, an infection or promote fracture healing and (iv) clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument. ETHICS AND DISSEMINATION: The BvV trial has been approved by a central institutional review board (IRB) (Advarra) for clinical sites in the USA, the ethics board at the coordinating centre at McMaster University (Hamilton Integrated Research Ethics Board), and participating sites not using the central institutional IRB (Fraser Health Research Ethics Board, The University of British Columbia Clinical Research Ethics Board, Newfoundland and Labrador Health Research Ethics Board, University of Manitoba Biomedical Research Ethics Board). Additional clinical sites who are in the start-up phase, as well as any new selected clinical sites, will obtain local approvals prior to initiating trial activities. This will include a clinical site in the UK who is in the process of obtaining the necessary approvals. Recruitment began in November 2023. Both interventions are frequently used to manage severe open fracture wounds, ensuring that the trial results can be easily transitioned into clinical practice. The results of this trial will be disseminated to national and international partners through peer-reviewed publications, academic conferences and stakeholder engagement activities. TRIAL REGISTRATION NUMBER: NCT05615844.