Reasons for exclusion* | Number of patients excluded during screening n=102 | Number of patients excluded following adjudication n=6 |
---|---|---|
Did not receive or will not receive definitive fracture treatment with a surgical implant(s) (e.g., internal fixation, external fixation, joint prosthesis), n (%) | 33 (32.4) | 2 (33.3) |
Open fracture wound management did not include a formal surgical debridement within 72 h of their injury, n (%) | 21 (20.6) | 2 (33.3) |
Likely problems, in the judgment of the study personnel, with maintaining follow-up, n (%) | 16 (15.7) | N/A |
Incarceration, n (%) | 8 (7.8) | N/A |
Did not provide informed consent, n (%) | 7 (6.9) | N/A |
Unable to obtain informed consent due to language barriers, n (%) | 6 (5.9) | N/A |
Received previous surgical debridement or management of their open fracture(s) at a non-participating hospital or clinic, n (%) | 4 (3.9) | N/A |
Expected injury survival of less than 90 days, n (%) | 4 (3.9) | N/A |
Open fracture(s) managed outside of the participating orthopedic service (e.g., hand fracture managed by plastic surgeon), n (%) | 1 (1.0) | N/A |
Burns at the fracture site, n (%) | 1 (1.0) | N/A |
Not enrolled within 3 weeks of their fracture, n (%) | 1 (1.0) | 1 (16.7) |
Patient enrolled during run-in phase | N/A | 1 (16.7) |