Randomized Controlled Trial: Use of Hydrocolloid Silver-Containing Wound Dressing after Sternotomy to Reduce Wound Complications after Cardiac Surgery

Objectives: Surgical site infections (SSIs) are a serious complication after cardiac surgery. New wound dressing techniques could reduce the incidence of SSIs. This prospective randomized industry-independent clinical trial investigates the influence of a hydrocolloid silver-containing wound dressing (AQUACEL Ag Surgical, HD) on the incidence of SSIs compared to the standard procedure.

Methods: A total of 423 elective CABG patients operated between January 2018 and July 2019 were randomized into conventional and HD wound management groups. According to our study protocol, 73 randomized patients were excluded (ventilation >  48 hours, n = 29; rethoracotomy, n = 10; HD not received, n = 10; no IMA, n = 8; no OP, n = 6; mortality, n = 5; immunosuppression drugs, n = 3; no CABG, n = 2). 350 patients (mean age 68 ± 9.4, 80% male) were randomized into control (n = 173) and study group (n = 177) and treated according to the study protocol. The HD was applied intraoperatively and remained five days. In the control group regular wound dressing was applied intraoperatively and changed the first time after 48 hours. After the fifth postoperative day, wounds in both groups remained without further dressings. Wounds were monitored daily until the 7th and on the 30th postoperative days. SSIs were classified into three categories (superficial, deep, and organ SSI) according to severity and need for treatment.

Results: No differences in demographics, cardiovascular risk factors, intraoperative process and postoperative care were found between both groups. The total SSI rate was 9.14% with 14 patients (8.1%) in the control and 18 patients (10.2%) in the study group (p = 0.5). The extent of SSIs in control and study group according to superficial (2.3 vs. 3.4%), deep (4.1 vs. 5.1%), and organ SSI (1.7 vs. 1.7%) showed no significant differences (p = 0.895). Twenty-five patients required surgical wound revision (6.4 vs. 7.9%; p = 0.573) 23.8 ± 12.9 days after primary surgery. Sixteen patients required VAC therapy and secondary closure (4.6 vs. 4.5%; p = 0.52).

Conclusion: No difference was found in the incidence or extent of wound healing disorder. The type of dressing therefore does not seem to have any influence on wound healing. Known patient-specific and intraoperative factors seem to play a significantly greater role in the development of wound healing disorders and should therefore be consistently considered.