Skip to main content

Table 1 Reasons for exclusion

From: Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study

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)

  1. *Please note that some patients were excluded for more than one reason. We present one reason per patient based on order of reason for exclusion in table