Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CONVAFoam Hydrofiber Dressing, Standard Pressure Injury Prevention Care.
- Who it may be relevant to
- Registry conditions: CAD - Coronary Artery Disease, CABG, Valve Disease, Heart, Aortic Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Using Soft Foam Dressings in Preventing Pressure Injuries During Cardiac Surger
Overview
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.
Detailed description
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)
Interventions
- Device CONVAFoam Hydrofiber Dressing
Add prophylactic application of CONVAFoam dressing to high-risk pressure areas (heels, sacrococcygeal region, hallux prominence) - Other Standard Pressure Injury Prevention Care
Routine perioperative pressure injury prevention measures including pressure-relieving pads, heel pads, positioning support, and cotton/towel separation according to institutional protocol.
Primary outcome measures
- Incidence of surgery-related pressure injuries [Time frame: From preoperative baseline (before surgery) to postoperative day 5]
Secondary outcome measures (2)
- Time to development of pressure injury [Time frame: From end of surgery to postoperative day 5]
- Severity stage of pressure injuries [Time frame: Postoperative day 1 to postoperative day 5]
Eligibility criteria
Inclusion criteria
- Adults aged 18 years or older
- Scheduled to undergo cardiac surgery under general anesthesia
- Use of cardiopulmonary bypass (CPB) during surgery
- Expected surgical duration greater than 4 hours
- Intact skin without pre-existing pressure injury prior to surgery
Exclusion criteria
- Surgical position other than supine
- Long-term bedridden status prior to hospital admission
- Altered consciousness or inability to cooperate
- History of stroke with residual limb weakness
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07379294 · KMUHIRB-F(I)-20250378