The use of a vacuum-assisted wound closure system (PICO, Fa. Smith \& Nephew) is being investigated to determine whether it reduces the incidence of sternal wound healing disorders compared to conventional wound care with plaster.
Median sternotomy remains the standard surgical approach for most cardiac surgeries. However, postoperative wound infections can occur and may progress to mediastinitis, a life-threatening complication with significant mortality. This risk is particularly pronounced in cases where sternal perfusion is compromised, such as when one or both internal mammary arteries are harvested during coronary artery bypass grafting. In such scenarios, the incidence of sternal wound healing disturbances is estimated to range from 2% to 7%. Several strategies aim to reduce the risk of sternal wound infections. One approach involves external stabilization using a thoracic vest, which has been shown to significantly decrease sternal instability and healing disorders when implemented early in the postoperative period. Another approach utilizes negative pressure wound therapy, which has demonstrated efficacy in reducing sternal wound healing complications in prior studies involving systems like Prevena (Fa. KCI). The PICO-System operates with a distinct vacuum pressure mechanism and a unique film design compared to the Prevena system. To date, no prospective randomized studies have evaluated the PICO-System for its effectiveness in reducing sternal healing disturbances, sternal instability, and mediastinitis. This study aims to compare conventional plaster wound care with the PICO vacuum system in a randomized, prospective design, assessing outcomes up to six months postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
For both groups, the same median sternotomy cardiac surgery procedure
Cardiac Surgery, Kerckhoff Heart Center
Bad Nauheim, Hesse, Germany
Cardiovascular Surgery, University Hospital Giessen
Giessen, Hesse, Germany
Infection at 30 POD
Rate of superficial or deep sternal wound healing disorders at 30 days postoperatively
Time frame: until day 30 post-surgery
Infection at 180 Postoperative Days (POD)
Rates of superficial and/or deep sternal wound healing disorders assessed using standardized clinical criteria, including infection signs (e.g., erythema, purulent discharge), radiological imaging (if indicated), microbiological culture results, and adherence to validated classification systems such as the CDC's surgical site infection (SSI) criteria.
Time frame: Up to 180 days post-surgery
Patient satisfaction
Patient satisfaction with the PICO-System in comparison to conventional plasters: The following questions were assessed to evaluate participant satisfaction: * The wound dressing causes discomfort. * My wound has achieved a satisfactory cosmetic appearance. * I experienced pain during wound dressing changes. * I am generally satisfied with the care provided. For each question, the following response options were offered: * Fully applies * Partially applies * Neutral * Partially does not apply * Does not apply
Time frame: until day 7 post-surgery
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