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| ID | Type | Description | Link |
|---|---|---|---|
| 2323 | Other Identifier | SFDA |
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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.
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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyurethane foams (Pink Pad) | Active Comparator | 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. |
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| Mepilex Border Sacrum dressings | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Border Sacrum dressings | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure ulcer incidence | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of pressure ulcer | The occurrence of pressure ulcer will be documented in data collection then calculated. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wedian O. Almowallad / Head of Clinical Trial Department, Master | Contact | 012 5549999 | Ext: 18008 | Almwlld.W@kamc.med.sa |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulla Medical City in Holy capital | Recruiting | Mecca | Western Reagan | 21955 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40791282 | Derived | 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. |
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individual participant data (IPD) will not be shared , but the data can be reviewed by regulatory officer
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2023 | Jan 21, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2023 | Nov 27, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Polyurethane foams (Pink Pad) | 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. |
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