Discussion
SSI, trauma
WOUND INFECTIONS, RECRUITMENT
This feasibility study has demonstrated that the recruitment and randomization of hand trauma patients to antimicrobial sutures is expeditious and achievable. Despite delays in site set-up resulting from the COVID-19 pandemic, we were able to recruit our target number within 8 months, closing the study to recruitment earlier than anticipated. This finding is particularly critical in hand trauma trials, where two NIHR-funded (Health Technology Assessment stream) RCTs have recently been closed due to recruitment issues as part of the ‘Future of UK Clinical Research Delivery: 2022 to 2025 implementation plan’Trial activity, including recruitment to HAWAII, was managed In terms of progression to a full definitive trial, parameters for screening, recruitment and retention were set in the protocol stageRetention was the key issue in terms of feasibility. At the primary analysis for a potential full trial, 30 days post surgery, we had only 57.5 per cent completion of remote electronic PROMs by participants. This dropped to 52.2 per cent by 90 days and 45.1 per cent by 6 months. While this is concerning and falls well below the target of >90 per cent or more, it provides useful feasibility information. Using primarily automated, electronic, remote follow-up only, we were able to achieve nearly 60 per cent retention at 30 days. Hand trauma affects a young, predominantly male population and therefore it is realistic to expect difficulties in following up this hard-to-reach populationBest-practice guidance for improving retention in RCTs was published in 2017The use of validated and efficient questionnaires in HAWAII was recommended by evidence and PPI workshop discussion. We used contemporary PROMs, delivered electronically. For PROMIS UE, we used the CAT version to improve efficiency and reduce questionnaire burden. Since this study, a CAT has been developed for the PEM, which could be incorporated into a future definitive study to reduce burden and improve completion rates, as well as having the added advantage of item response theory, validated, interval scale measurementDespite poor retention, useful follow-up data were attained that can inform a definitive study. All participants who did respond completed all questionnaires sent to them, resulting in complete data for all responders. Three wound infections were reported by sites, all occurring in participants allocated to standard sutures. One occurred in a wound distant to the trial wound but on the same limb. The other two were superficial SSIs requiring oral antibiotics only. Using only these data, the SSI risk in this study would be 2.7 per cent. At 30 days, 65 participants had completed the BWHQ. This includes self-reporting of interventions to treat SSI and so gives a different angle to the site-reported figures, including those that had been managed in primary care. Across both groups, 15 participants reported having received an intervention for SSI by 30 days: 23.1 per cent. Of these, 11 required a surgical intervention, while 8 required antibiotics alone. By 90 days, 59 had completed the BWHQ and 12 had reported receiving interventions for SSI, 20.3 per cent, 10 of whom underwent a physical intervention and 6 had oral antibiotics.The use of adjunctive antimicrobial interventions, including antibiotics, provides useful feasibility data for future studies in this area. A meta-analysis of antibiotics in hand trauma found no evidence of effect in terms of reducing SSI, although this review was limited by low-quality primary dataIn terms of improving efficiency of a future definitive trial of antimicrobials in hand trauma surgery, the use of linked real-world data to improve follow-up data completion could be advantageous