NCT06790277

Polyurethane Foam-Pink Pad (RCT) Use in OR

Effectiveness of Polyurethane Foam (Pink Pad) Compared With Mepilex Dressing for Pressure Ulcer Prevention in Operating Room: A Randomized Control Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: King Abdullah Medical City · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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,

Conditions

• Cardiac Surgery Subjects
• Pressure Ulcer Prevention
• Pressure Ulcer of Skin
• Pressure Ulcer

Interventions

Type	Name	Description
DEVICE	Mepilex 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.
DEVICE	Polyurethane 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.

Timeline

• Start date: 2023-10-10
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: Saudi Arabia