Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery

Shih,Wen-Chi

Status: Not yet enrolling

Conditions: Expected Surgical Duration > 4 Hours; Patients Undergoing Cardiac Surgery Under General Anesthesia (e.g., AVR, MVR, DVR, CABG, Type A Repair, Bentall Procedure, Heart Transplantation); Age ≥ 18 Years; Use of Cardiopulmonary Bypass (CPB) During Surgery; Intact Skin Preoperatively, With no Existing Pressure Injuries

Treatments: Other: Control group; Other: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT07379294

KMUHIRB-F(I)-20250378

Details and patient eligibility

About

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.

Full 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)

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Experimental Group

Experimental group

Description:

AQUACEL Foam Hydrofiber Dressing

Treatment:

Other: Intervention group

Control Group

Other group

Description:

Standard pressure injury prevention care

Treatment:

Other: Control group