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NCT Number: NCT07379294

Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CONVAFoam Hydrofiber Dressing

Device

Add prophylactic application of CONVAFoam dressing to high-risk pressure areas (heels, sacrococcygeal region, hallux prominence)

Other names: CONVAfoam

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.

Primary outcomes

  1. Incidence of surgery-related pressure injuries

    Time frame: From preoperative baseline (before surgery) to postoperative day 5

    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.

Secondary outcomes

  1. Time to development of pressure injury

    Time frame: From end of surgery to postoperative day 5

    The time (in days) from surgery completion to the first documented occurrence of a pressure injury.

  2. Severity stage of pressure injuries

    Time frame: Postoperative day 1 to postoperative day 5

    The highest NPIAP stage of any pressure injury observed during the 5 postoperative days.

Other outcomes

  1. Cardiopulmonary Bypass Duration

    Time frame: During surgery

    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.

  2. CPB Temperature at Termination

    Time frame: At the time of cardiopulmonary bypass termination during surgery

    To investigate the correlation between core temperature (°C) at the termination of cardiopulmonary bypass and pressure injury.

  3. Lowest Cardiopulmonary Bypass Temperature

    Time frame: From initiation to termination of cardiopulmonary bypass during surgery

    To investigate the correlation between the temperature at which the body is cooled to its lowest point during (°C) cardiopulmonary bypass and pressure injury.

Sponsors and collaborators

Lead sponsor

Shih,Wen-Chi

Other

Registry information

Official study title

Effectiveness of Using Soft Foam Dressings in Preventing Pressure Injuries During Cardiac Surger

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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