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Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery

ConditionsCAD - Coronary Artery DiseaseCABGValve Disease, HeartAortic DiseasesValve Heart StenosisAortic AneurysmMitral DiseaseAORTIC VALVE DISEASESAortic Dissection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShih,Wen-Chi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • CONVAFoam Hydrofiber Dressing

    Device

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

  • Standard Pressure Injury Prevention Care

    Other intervention

    Routine perioperative pressure injury prevention measures including pressure-relieving pads, heel pads, positioning support, and cotton/towel separation according to institutional protocol.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Prophylactic soft foam DressingExperimental treatment 2 interventions
Group B: Standard Pressure Injury Prevention CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

Time to development of pressure injury

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

Time frame
From end of surgery to postoperative day 5
2

Severity stage of pressure injuries

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

Time frame
Postoperative day 1 to postoperative day 5

Other outcomes

1

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.

Time frame
During surgery
2

CPB Temperature at Termination

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

Time frame
At the time of cardiopulmonary bypass termination during surgery
3

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.

Time frame
From initiation to termination of cardiopulmonary bypass during surgery

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shih,Wen-Chi

Lead sponsor

Fu Jen Catholic University Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: