Development of a 3D Spacer Mattress for Pressure Relieving in Cardiac Surgery and Evaluation of Its Efficacy

Study Overview
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Brief Summary
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In this study, researchers developed a mattress made of 3D spacer fabric to relieve pressure during cardiovascular surgery. Following the development process, an initial assessment of the mattress's effectiveness was carried out on healthy volunteers. The same people lay first on the developed product and then on the surgical mattress in the supine position. In both cases, the pressure between the person and the mattress was measured using a force-sensitive resistor (using Interlink's FRS-406 series sensors). Thirty patients were included in the initial evaluation. A randomised controlled trial was then carried out with patients undergoing surgery (patients were divided into two groups; (a) mattress developed by the researchers and (b) standard operating theatre mattress). Sixty patients were divided into two groups using block randomisation. In the block randomisation, patients below or above body mass index 27 were equally distributed between the groups. Pressure levels were measured continuously during surgery using the same sensors.

Detailed Description
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In this study, the researchers developed a mattress made of 3D spacer fabric for pressure relief during cardiovascular surgery. Following the development process, an initial assessment of the mattress's effectiveness was carried out on healthy volunteers. The same people lay first on the developed product and then on the surgical mattress in the supine position. In both cases, the pressure between the person and the mattress was measured using a force-sensitive resistor (using Interlink's FRS-406 series sensors). 30 patients were included in the initial evaluation. A randomised controlled trial was then carried out with patients who underwent surgery (patients were divided into two groups; (a) mattress developed by the researchers and (b) operating theatre mattress in common use). 60 patients were divided into two groups using block randomisation. In the block randomisation, patients below or above body mass index 27 were evenly distributed between the groups. Pressure levels were continuously measured during surgery using the same sensors. Data were analysed using IBM SPSS software v26.

Official Title
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Development of a 3D Spacer Mattress for Pressure Relieving in Cardiac Surgery and Evaluation of Its Efficacy

Conditions
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Pressure Ulcer, Cardiac Surgery

Intervention / Treatment
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* Combination Product: 3D spacer Fabric Based Mattress


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Being 18 years or older Not having a pressure ulcer prior to surgery Agreeing to participate in the study Exclusion criteria: - Not agreeing to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There were two groups in the trial. The first group was the group in which the patients used the mattress developed by the researcher. This was the intervention group. In the second group, the patients used the standard operating theatre mattress. This was the control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D Spacer Mattress<br>For the patients in this group, the mattress which developed by the researchers was used. Pressure level between the body and the mattress was measured throughout the surgery. | Combination Product: 3D spacer Fabric Based Mattress<br>* For the patients in the intervention group, the 3D spacer fabric-based mattress was used instead of the operating room theater mattress. The pressure level of the patients was monitored throughout the surgery.<br>|
| No Intervention: Operating Room Mattress<br>For the patients in this group, the mattress which was in common use was used. The mattress used for the patients in this group was made up of foam. The pressure level between the body and the mattress was measured throughout the surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure level | Pressure between the product surface and patients' body | through study completion, an average of 1 yea | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcer, Operating room, Cardiac Surgery