NCT06071039

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: İsmail TOYGAR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Pressure Ulcer
• Cardiac Surgery

Interventions

Type	Name	Description
COMBINATION_PRODUCT	3D spacer Fabric Based Mattress	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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2023-10-06
• Last updated: 2023-10-06

Locations

1 site across 1 country: Turkey (Türkiye)