Cardiac Surgery Subjects, Pressure Ulcer, Pressure Ulcer of Skin, Pressure Ulcer Prevention
Conditions
Keywords
five layers sacral foam dressing, PINK PAD, pressure ulcers, Patients undergoing cardiac surgery, Mepilex dressing
Brief summary
King Abdullah medical city has a cardiac center, and a lot of open-heart surgeries are performed there, and both polyurethane foam (pink Pad) and Mepilex dressing are applied to those patients. Therefore, the present study was designed to compare the effects of polyurethane foam (pink Pad) versus Mepilex dressing for prevention of pressure ulcer in operating room.
Detailed description
There are two types of intervention available in King Abdullah medical city for operating room pressure ulcer prevention. Polyurethane foams (Pink Pad) are a single use system for use in surgical procedures. The system consists of a proprietary formulation for the pink foam pad, non-woven lift sheet, body straps, head rests, and boot liners. It aids hospital facilities in providing a safe and effective method of management of the patient for pressure ulcers and non-movement for patients in the Trendelenburg position. Mepilex Border Sacrum dressings are self-adherent, multilayer foam dressings designed for use on sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention. All included patients received standard PU prevention according to hospital protocols, based on contextualization and adaptation of International guidelines ( European Pressure Ulcer Advisory Panel, 2021 ), which involved: assessment of PU risk through the Braden Scale at hospital admission,
Interventions
DEVICEMepilex Border Sacrum dressings
Both types of intervention will be available in the operating room. Patient will be examined by head nurse of wound management team after the operation then at day 3- and 7-days post operation. The dressing should be removed after 7 days post operation or if there is any clinical indication for removal. If a patient is discharged before 7 days post operation for any reason the head nurse of wound management team will examine the patient before discharge. Follow up will be for maximum 7 days post operation for each subject. Any patient will be unable to continue the study because of death or change in the care setting will be excluded from the study.
DEVICEPolyurethane foams (Pink Pad)
Both types of intervention will be available in the operating room. Patient will be examined by head nurse of wound management team after the operation then at day 3- and 7-days post operation. The dressing should be removed after 7 days post operation or if there is any clinical indication for removal. If a patient is discharged before 7 days post operation for any reason the head nurse of wound management team will examine the patient before discharge. Follow up will be for maximum 7 days post operation for each subject. Any patient will be unable to continue the study because of death or change in the care setting will be excluded from the study.
Sponsors
King Abdullah Medical City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects ≥ 18. * Willing to participate. * Patients undergoing cardiac surgery. * Patient who is at risk for PU development as measured with Braden scale. * Patient who has skin intact and having a life expectancy greater than 72 hours as per clinical judgement.
Exclusion criteria
* Subjects under 17 * Not consenting to participate * Patients with suspected hypersensitivity reactions to any of the dressing formulation's ingredients. * Patients who are unable to continue the study because of death or change in the care setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure ulcer incidence | 7 days | Pressure ulcer incidence will be assessed by using Bates-Jensen Wound Assessment Tool (BWAT) after operation then day 3 and day 7 for both treatments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of pressure ulcer | 7 days | The occurrence of pressure ulcer will be documented in data collection then calculated. |
Countries
Saudi Arabia
Contacts
Primary ContactWedian O. Almowallad / Head of Clinical Trial Department, Master
Outcome results
None listed