Polyurethane Foam-Pink Pad (RCT) Use in OR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Abdullah Medical City
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects ≥ 18.
Willing to participate.
Patients undergoing cardiac surgery.
Patient who is at risk for PU development as measured with Braden scale.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Mepilex Border Sacrum dressings
DeviceBoth 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)
DeviceBoth 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Polyurethane foams (Pink Pad)Active comparator 1 intervention
Group B: Mepilex Border Sacrum dressingsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
7 daysSecondary outcomes
1
occurrence of pressure ulcer
The occurrence of pressure ulcer will be documented in data collection then calculated.
Time frame
7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov