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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06071039
Enrollment
60
Registered
2023-10-06
Start date
2023-02-01
Completion date
2023-09-22
Last updated
2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Pressure Ulcer

Keywords

Pressure ulcer, Operating room, Cardiac Surgery

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.

Interventions

COMBINATION_PRODUCT3D 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.

Sponsors

Bahçeşehir University
CollaboratorOTHER
İsmail TOYGAR
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pressure levelthrough study completion, an average of 1 yeaPressure between the product surface and patients' body

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026