- •Four arm Randomised Control Superiority Trial.
- •Comparison of effectiveness of three antiseptics against control in routine pin site care in Ilizarov external fixators.
- •Daily and weekly pin site care regimens within each group.
- •No superiority of any antiseptic over control in reducing the burden of pin site infection.
- •Daily pin site care not superior to weekly pin site care.
Pin site infection is the commonest complication of Ilizarov external fixation. The aim of the study was to examine if use of antiseptics was superior over control and further if daily dressing was superior to weekly dressing in regular pin site care in reducing the burden of pin site infection in Ilizarov fixators.
Patients and methods
A total of 114 patients (2363 pin sites) were randomised to receive regular pin site care alone (30 patients, 638 pin sites) or with additional application of povidone iodine (27 patients, 561 pin sites), silver sulfadiazine (27 patients, 570 pin sites) and chlorhexidine (30 patients, 594 pin sites). The pin tracts were sub-randomised to receive daily (1212 pin sites) or weekly (1151 pin sites) dressings. The primary outcome was pin site infection days rate across all four groups. The secondary outcomes were - mean duration to first episode of infection, differences between daily and weekly dressing groups, mean duration of antibiotic therapy and incidence of re-interventions and sequelae. We also recorded frequency of bacterial pathogens in all microbiological samples submitted. Block randomization using computer-generated random numbers was used. The assessor of outcome was blinded.
All patients completed the study. Pin site infection rate days per 1000 pin site days observed was marginally less in chlorhexidine group, but was not statistically significant compared to other antiseptics and control group (Absolute value in control, povidone iodine, silver sulphadiazine and chlorhexidine groups were respectively 2.04 ± 4.27, 2.04 ± 3.65, 1.85 ± 3.37, 1.37 ± 2.35, p value 0.92). Daily dressing category showed slightly less pin site infection days rate within each group and overall, but this was also not statistically significant (1.56 ± 3.99 versus 2.10 ± 5.1, p value 0.35). There was no statistically significant difference among the groups with regard to other secondary outcomes. Methicillin Sensitive Staphylococcus aureus was the most common bacterial pathogen isolated.
Use of antiseptics does not offer any advantage in regular pin site care in Ilizarov external fixation and daily pin site care is not superior to weekly pin site care. Empirical therapy in early and low grade pin site infections must be targeted against Staphylococcus.
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Published online: January 23, 2019
Accepted: January 23, 2019
☆The work was done at Dept of Orthopaedics, Sri Sathya Sai Institute of Higher Medical Sciences - Prashanthigram, Puttaparthi, Andhra Pradesh, India – 515134.
© 2019 Elsevier Ltd. All rights reserved.