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The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery. Specifically, this research aims to investigate differences in pressure injury outcomes before and after the intervention, and to assess the preventive effectiveness of soft foam dressings as an adjunctive skin-protection strategy.
The goal of this clinical trial is to learn if applying soft foam dressings (AQUACEL Foam Hydrofiber Dressing) can prevent surgery-related pressure injuries in adult patients (≥18 years) undergoing cardiac surgery under general anesthesia with cardiopulmonary bypass (CPB). The main questions it aims to answer are:
Does the use of soft foam dressings reduce the incidence of perioperative pressure injuries compared with routine skin protection measures alone? Does the intervention delay the time to pressure injury development and improve postoperative skin integrity during the first 5 postoperative days? Researchers will compare the intervention group (routine prevention + AQUACEL Foam applied to high-risk pressure areas) to the control group (routine prevention only) to see if the foam dressing intervention reduces pressure injury occurrence after cardiac surgery.
Participants will:
Be screened for eligibility and provide written informed consent Receive either routine pressure injury prevention care alone (control group) or routine care plus AQUACEL Foam dressings (intervention group) applied to pressure-prone areas (e.g., heels, sacrococcygeal region, and hallux bony prominence) Complete a demographic questionnaire (approximately 10 minutes; self-completed or assisted by the researcher)
Undergo skin assessments 6 times:
T0: during preoperative preparation T1: immediately after surgery T2-T5: once daily for 4 consecutive days after ICU transfer Have perioperative and clinical data collected from medical records (e.g., surgical duration, CPB time/temperature, laboratory values such as albumin, Hb, RBC, Hct, BUN, creatinine)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic soft foam Dressing | Experimental | In addition to general routine skin protection measures, also add soft foam dressings. |
|
| Standard Pressure Injury Prevention Care | Active Comparator | General routine skin protection measures (fatty pressure relief pads, cotton rolls or towels to isolate tubing, heel pads, etc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONVAFoam Hydrofiber Dressing | Device | Add prophylactic application of CONVAFoam dressing to high-risk pressure areas (heels, sacrococcygeal region, hallux prominence) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of surgery-related pressure injuries | The occurrence of new pressure injuries at any anatomical site, assessed using NPIAP staging criteria. Skin assessments will be performed by trained staff at predefined perioperative time points to determine whether a pressure injury develops after surgery. | From preoperative baseline (before surgery) to postoperative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to development of pressure injury | The time (in days) from surgery completion to the first documented occurrence of a pressure injury. | From end of surgery to postoperative day 5 |
| Severity stage of pressure injuries |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiopulmonary Bypass Duration | The correlation between the time from the start to the end of cardiopulmonary bypass and pressure injury was investigated, and the total time of cardiopulmonary bypass (in minutes) was measured. | During surgery |
| CPB Temperature at Termination |
Inclusion Criteria:
Exclusion Criteria:
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All preventive measures will be applied after induction of anesthesia; therefore, participants will be unable to know which study group they are assigned to. In addition, the foam dressing and/or other protective measures will be removed at the end of surgery, further ensuring that participants remain unaware of their group allocation after the procedure.
|
| Standard Pressure Injury Prevention Care | Other | Routine perioperative pressure injury prevention measures including pressure-relieving pads, heel pads, positioning support, and cotton/towel separation according to institutional protocol. |
|
The highest NPIAP stage of any pressure injury observed during the 5 postoperative days.
| Postoperative day 1 to postoperative day 5 |
To investigate the correlation between core temperature (°C) at the termination of cardiopulmonary bypass and pressure injury. |
| At the time of cardiopulmonary bypass termination during surgery |
| Lowest Cardiopulmonary Bypass Temperature | To investigate the correlation between the temperature at which the body is cooled to its lowest point during (°C) cardiopulmonary bypass and pressure injury. | From initiation to termination of cardiopulmonary bypass during surgery |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| D001018 | Aortic Diseases |
| D001014 | Aortic Aneurysm |
| D004194 | Disease |
| D000082862 | Aortic Valve Disease |
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000783 | Aneurysm |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
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