CAD - Coronary Artery DiseaseNCT07379294
Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery
A study testing CONVAFoam Hydrofiber Dressing and Standard Pressure Injury Prevention Care in people with CAD - Coronary Artery Disease and CABG, run by Shih,Wen-Chi.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAD - Coronary Artery Disease, CABG, Valve Disease, Heart
- What is being tested?
- CONVAFoam Hydrofiber Dressing and Standard Pressure Injury Prevention Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2026to 30 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effectiveness of Using Soft Foam Dressings in Preventing Pressure Injuries During Cardiac Surger
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.
Read the 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)
- Conditions
- CAD - Coronary Artery Disease, CABG, Valve Disease, Heart, Aortic Diseases, Valve Heart Stenosis, Aortic Aneurysm
- Being tested
- CONVAFoam Hydrofiber Dressing, Standard Pressure Injury Prevention Care
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases, Aortic Diseases, Aortic Aneurysm, Disease, Aortic Valve Disease, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONVAFoam Hydrofiber DressingDevice
Also called CONVAfoam
Add prophylactic application of CONVAFoam dressing to high-risk pressure areas (heels, sacrococcygeal region, hallux prominence)
Standard Pressure Injury Prevention CareOther
Routine perioperative pressure injury prevention measures including pressure-relieving pads, heel pads, positioning support, and cotton/towel separation according to institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic soft foam Dressing | Experimental | In addition to general routine skin protection measures, also add soft foam dressings. Receives: Device: CONVAFoam Hydrofiber Dressing; Other: Standard Pressure Injury Prevention Care |
| 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.) Receives: Other: Standard Pressure Injury Prevention Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From preoperative baseline (before surgery) to postoperative day 5
Secondary outcomes (2)
Time to development of pressure injury
The time (in days) from surgery completion to the first documented occurrence of a pressure injury.
Measured: From end of surgery to postoperative day 5
Severity stage of pressure injuries
The highest NPIAP stage of any pressure injury observed during the 5 postoperative days.
Measured: Postoperative day 1 to postoperative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start31 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shih,Wen-Chi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shih,Wen-Chi, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379294
- Sponsor's protocol ID
- KMUHIRB-F(I)-20250378
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No