Is the Risk of Wound Infection Related to Bilateral Internal Thoracic Artery Graft Potentiated by Age?

BACKGROUND: Older age and the use of bilateral internal thoracic artery (ITA) grafting are both considered risk factors for surgical wound infection (SWI) after coronary artery bypass grafting (CABG). The 2014 European Guidelines recommend that bilateral ITA grafting should be considered in patients aged younger than 70 years. Our aim was to investigate interaction between age and the number of ITA grafts. METHODS: All patients aged 18 years and older who had undergone CABG with at least 1 ITA at Rouen University Hospital between 2001 and 2012 were selected. Data regarding surgical procedure (single/bilateral ITA grafting) were extracted from the medical information system. SWI was identified from prospective surveillance of patients according to Centers for Disease Control and Prevention criteria. Independent factors associated with SWI were assessed by logistic regression, and an interaction test between age (≤69 or ≥70 years) and the number of ITA grafts was performed. RESULTS: SWI occurred in 71 of 2,726 patients (2.6%). Bilateral ITA grafting was associated with SWI (adjusted odds ratio [aOR], 2.55; 95% confidence interval, 1.51 to 4.30). After fitting an interaction term between age and number of ITA grafts, the aORs for SWI after bilateral ITA grafting substantially differed between patients aged 69 years and younger (aOR, 1.88; 95% confidence interval, 0.94 to 3.75) and 70 years and older (aOR, 3.52; 95% confidence interval, 1.69 to 7.33). However, this interaction failed to reach statistical significance (p = 0.2213), possibly because of insufficient statistical power (23.5%) despite the large sample size. CONCLUSIONS: Age 70 years and older compared with age 69 years and younger was associated with higher occurrence of SWI after bilateral ITA grafting, but this interaction was not statistically significant. Larger studies are needed to test this interaction.

Strategy for recruitment and factors associated with motivation and satisfaction in a randomized trial with 210 healthy volunteers without financial compensation.

BACKGROUND: The aim was to describe a strategy for recruitment of healthy volunteers (HV) to a randomized trial that assessed the efficacy of different telephone techniques to assist HV in performing cardiac massage for vital emergency. Participation in the randomized trial was not financially compensated, however HV were offered emergency first-aid training. We also studied factors associated with HV motivation and satisfaction regarding participation in the trial. METHODS: Strategy for recruitment of 210 HV aged 18 to 60 years was based on: (1) the updated records of all telephone number since January 2000 of HV registered in the Rouen Clinical Investigation Centre HV database, (2) a communication campaign for the general public focussing on posters and media advertisements. Data on the recruitment, socio-demographics, motivation and satisfaction of the 210 HV were collected by anonymous self-administered questionnaire. RESULTS: Of the 210 HV included, 63.3% (n = 133) were recruited from the HV database and 36.7% (n = 77) by the communication campaign. On the one hand, the HV database enabled screening of 1315 HV, 54.8% (n = 721) of whom were reached by phone, 55.2% (n = 398) of these latter accepted to participate in the study and 10.1% of the initial screening (n = 133) were finally included. One the other hand, for the 77 HV not recruited from the HV database, word-of-mouth (56.1%) was the main means of recruitment. The male/female ratio of the 210 HV was 0.5 and mean age 43.5 years (Standard Deviation = 12.4). The main motivations given for participating in the trial were to support research (87.6%) and receive emergency first-aid training (85.7%). Overall satisfaction with the welcome process was significantly higher for older HV (46-60 years) (adjusted odds ratio (AOR): 3.44; 95% confidence interval (95% CI): 1.48-7.99), and for HV in management jobs (AOR: 4.26; 95% CI: 1.22-14.87). Satisfaction with protocol management was higher for women (AOR: 2.33; 95% CI: 1.18-4.60) and for older HV (46-60 years) (AOR: 4.76; 95% CI: 1.97-11.52). CONCLUSIONS: Recruitment of non-compensated HV required broad screening with a primary HV database alongside word-of-mouth communication which seemed more efficient than media advertising. To enhance HV recruitment to randomized trials without financial compensation it seems crucial to provide them not only with a direct interest but also to ensure their satisfaction.