Table 3 Feasibility outcomes
Feasibility outcomes | Feasibility criteria | Pilot study results n (%) | Feasibility criteria met |
|---|---|---|---|
Implementation of the two trial interventions during the 1-month run-in period, n (%) | At least 15 eligible open fracture patients with >90% of eligible patients receiving the allocated antiseptic solution or a minimum of 1 month in duration | Total: 18/18 (100%) STC: 15/15 (100%) HGH: 3/3 (100%) | Yes |
Enrollment of participants across the two planned 2-month enrollment phases, n (%) | Enrollment of >75% of open fracture patients over each of the two 2-month enrollment periods | Total: 108/117 (92%) STC: 83/91 (91%) HGH: 25/26 (96%) | Yes |
Participants receiving trial interventions as per the cluster randomization crossover scheme, n (%) | >95% of participants receiving the treatment as per the cluster randomization on their initial surgery | Total: 106/108 (98%) STC: 81/83 (97%) HGH: 25/25 (100%) | Yes |
Rates of Participant Follow-up, n (%) | Participant follow-up of >95% at 90-day post-fracture surgery. | Total: 106/108 (98%) STC: 81/83 (97%) HGH: 25/25 (100%) | Yes |
Accurate documentation of the primary outcome, n (%) | Accurate documentation of >95% of the primary outcome (SSI) (i.e., less than 5% error rate in the documentation of the primary outcome). | Total: 100% | Yes |