Polyurethane Foam-Pink Pad (RCT) Use in OR

NCT ID: NCT06790277

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2025-10-10

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,

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Polyurethane foams (Pink Pad)

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.

Group Type: ACTIVE_COMPARATOR

Polyurethane foams (Pink Pad)

Intervention Type: DEVICE

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.

Mepilex Border Sacrum dressings

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.

Group Type: ACTIVE_COMPARATOR

Mepilex Border Sacrum dressings

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdullah Medical City

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ebtisam Abdellatif Ebrahim Elhihi

Nursing Research and Evidence Based Practice Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Abdulla Medical City in Holy capital

Mecca, Western Reagan, Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Wedian O. Almowallad / Head of Clinical Trial Department, Master

Role: CONTACT

Almwlld.W@kamc.med.sa

012 5549999 ext. Ext: 18008

Facility Contacts

wedian O Almowallad

Role: primary

Almwlld.W@kamc.med.sa

: 012 5549999 ext. Ext: 18008

References

Elhihi EA, Almuwallad SA, Alqrashi BM, Nada EM, Alduaiji NA, Alfakeeh AA. Effectiveness of a Single-Use Polyurethane Foam Positioning Pad Compared With Five-Layer Foam Sacral Dressing for Pressure Ulcer Prevention in the Operating Room: A Randomized Controlled Clinical Trial. Health Sci Rep. 2025 Aug 10;8(8):e70963. doi: 10.1002/hsr2.70963. eCollection 2025 Aug.

Reference Type: DERIVED

PMID: 40791282 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2323

Identifier Type: OTHER

Identifier Source: secondary_id

23-1093

Identifier Type: -

Identifier Source: org_study_id