Cardiac Surgery Subjectspink-padNCT06790277
Polyurethane Foam-Pink Pad (RCT) Use in OR
A study testing Mepilex Border Sacrum dressings and Polyurethane foams (Pink Pad) in people with Cardiac Surgery Subjects and Pressure Ulcer Prevention, run by King Abdullah Medical City at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Subjects, Pressure Ulcer Prevention, Pressure Ulcer of Skin
- What is being tested?
- Mepilex Border Sacrum dressings and Polyurethane foams (Pink Pad)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Oct 2023to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wedian O. Almowallad / Head of Clinical Trial Department, Master contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulla Medical City in Holy capital
Mecca, Western Reagan, 21955
wedian O Almowallad, : 012 5549999 ext. Ext: 18008, Almwlld.W@kamc.med.sa
Ebtisam Abd Elatif Ebrahim
About this study
Official title: Effectiveness of Polyurethane Foam (Pink Pad) Compared With Mepilex Dressing for Pressure Ulcer Prevention in Operating Room: A Randomized Control Clinical Trial
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.
Read the 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
- Being tested
- Mepilex Border Sacrum dressings, Polyurethane foams (Pink Pad)
- Keywords
- five layers sacral foam dressing, PINK PAD, pressure ulcers, Patients undergoing cardiac surgery, Mepilex dressing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex Border Sacrum dressingsDevice
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Polyurethane foams (Pink Pad) |
| 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. Receives: Device: Mepilex Border Sacrum dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
occurrence of pressure ulcer
The occurrence of pressure ulcer will be documented in data collection then calculated.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start10 Oct 2023
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ebtisam Abdellatif Ebrahim Elhihi, King Abdullah Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790277
- Sponsor's protocol ID
- 23-1093
- Other IDs
- 2323
- Acronym
- pink-pad
- Status last verified
- Jan 2025
- First submitted
- 25 Nov 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) will not be shared , but the data can be reviewed by regulatory officer
Publications
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.
PubMed 40791282
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Polyurethane Foam (Pink Pad) Compared With Mepilex Dressing for Pressure Ulcer Prevention in Operating Room: A Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT06790277
- Acronym / sponsor ID
- pink-pad / 23-1093
- Conditions
- Cardiac Surgery Subjects, Pressure Ulcer Prevention, Pressure Ulcer of Skin, Pressure Ulcer
- Keywords
- five layers sacral foam dressing, PINK PAD, pressure ulcers, Patients undergoing cardiac surgery, Mepilex dressing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King Abdullah Medical CityOther government
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyurethane foams (Pink Pad) | Active comparator | Device: 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. |
| Mepilex Border Sacrum dressings | Active comparator | Device: Mepilex Border Sacrum dressingsa 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepilex Border Sacrum dressingsBoth 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 | Mepilex Border Sacrum dressings |
| 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. | Device | Polyurethane foams (Pink Pad) |
Primary outcome
Pressure ulcer incidence
Time frame: 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.
1 secondary outcome
occurrence of pressure ulcer
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 40791282Elhihi 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.
- Individual participant dataSharing planned: No. individual participant data (IPD) will not be shared , but the data can be reviewed by regulatory officer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wedian O. Almowallad / Head of Clinical Trial Department, Master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Border Sacrum dressings and Polyurethane foams (Pink Pad) in people with Cardiac Surgery Subjects and Pressure Ulcer Prevention, run by King Abdullah Medical City at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wedian O. Almowallad / Head of Clinical Trial Department, Master (012 5549999 ext. Ext: 18008, Almwlld.W@kamc.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure ulcer incidence (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06790277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025; AzTrials last refreshed its copy on 1 Nov 2026.