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

Not Applicable

Completed

• Conditions: Pressure Ulcer; Cardiac Surgery
• Interventions: Combination Product: 3D spacer Fabric Based Mattress

• Registration Number: NCT06071039
• Lead Sponsor: İsmail TOYGAR

Brief 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.

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-09-22
• Study Completion: 2023-09-22
• Study First Submitted: 2023-09-23
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D Spacer Mattress	3D spacer Fabric Based Mattress	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.

Primary Outcome Measures

Name	Time	Method
Pressure level	through study completion, an average of 1 yea	Pressure between the product surface and patients' body

Trial Locations

Locations (1)

Şehit Prof. Dr. İlhan Varank Education and Research Hospital; 🇹🇷 Istanbul, Turkey