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

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.

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Key information

Conditions

Pressure Ulcer Cardiac Surgery Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Şehit Prof. Dr. İlhan Varank Education and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D spacer Fabric Based Mattress

Combination Product

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.

Primary outcomes

Pressure level

Time frame: through study completion, an average of 1 yea

Pressure between the product surface and patients' body

Sponsors and collaborators

Lead sponsor

İsmail TOYGAR

Other

Collaborators

Bahçeşehir University

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Oct 6, 2023
Registry last updated: Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed