Polyurethane Foam-Pink Pad (RCT) Use in OR (pink-pad)

King Abdullah Medical City

Status: Enrolling

Conditions: Cardiac Surgery Subjects; Pressure Ulcer; Pressure Ulcer of Skin; Pressure Ulcer Prevention

Treatments: Device: Polyurethane foams (Pink Pad); Device: Mepilex Border Sacrum dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT06790277

23-1093

2323 (Other Identifier)

Details and patient eligibility

About

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.

Full 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,

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Polyurethane foams (Pink Pad)

Active Comparator group

Description:

a single use system for use in surgical procedures.it will be used only by operating room nurses Patient will be examined by wound management team after the operation then at day 3- and 7-days post operation.

Treatment:

Device: Polyurethane foams (Pink Pad)

Mepilex Border Sacrum dressings

Active Comparator group

Description:

a single use system for use in surgical procedures.it will be used only by operating room nurses Patient will be examined by wound management team after the operation then at day 3- and 7-days post operation.

Treatment:

Device: Mepilex Border Sacrum dressings