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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
| Kerckhoff Heart Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICO arm | Experimental | PICO vacuum system for post-sternotomy wound |
|
| Control arm | Active Comparator | usual commercial wound dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac surgery via median sternotomy | Procedure | For both groups, the same median sternotomy cardiac surgery procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infection at 30 POD | Rate of superficial or deep sternal wound healing disorders at 30 days postoperatively | until day 30 post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 180 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-Effectiveness of PICO Wound Dressing Compared to Conventional Plaster Dressing | The cost-effectiveness analysis will assess the direct and indirect costs associated with the use of PICO vacuum-assisted wound dressings compared to conventional plaster dressings in patients undergoing median sternotomy. Costs will include initial purchase price, frequency of dressing changes, associated resource utilization (e.g., hospital readmissions, additional interventions for wound healing disorders), and postoperative complications such as sternal instability, wound infections, and mediastinitis. Data will be aggregated and reported using descriptive statistics, incremental cost-effectiveness ratios. |
Inclusion Criteria:
All patients undergoing cardiac surgery by means of median sternotomy and exhibiting more than one of the following risk factors:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Surgery, Kerckhoff Heart Center | Bad Nauheim | Hesse | 61231 | Germany | ||
| Cardiovascular Surgery, University Hospital Giessen |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Patient satisfaction | Patient satisfaction with the PICO-System in comparison to conventional plasters: The following questions were assessed to evaluate participant satisfaction:
For each question, the following response options were offered:
| until day 7 post-surgery |
| From surgery to day 180 post-surgery |
| Giessen |
| Hesse |
| 35392 |
| Germany |