NCT06071039

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

Completed NA Last updated 6 October 2023

What this trial tests

NA trial testing 3D spacer Fabric Based Mattress in Pressure Ulcer in 60 participants. Completed in 22 September 2023.

Timeline

1 February 2023

Primary endpoint
22 September 2023

22 September 2023

Quick facts

Lead sponsor	İsmail TOYGAR
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	60
Start date	1 February 2023
Primary completion	22 September 2023
Estimated completion	22 September 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• 3D spacer Fabric Based Mattress

Conditions studied

• Pressure Ulcer — all drugs for Pressure Ulcer →
• Cardiac Surgery — all drugs for Cardiac Surgery →

Sponsor

İsmail TOYGAR

Who can join

18 and older, any sex, with Pressure Ulcer or Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development of a Three-dimensional Spacer Mattress for Pressure Relief in Cardiac Surgery and Evaluation of Its Efficacy: A Feasibility Study.
   İşler Işildak Y, Eti Aslan F, Korkmaz E, Çömez L, et al · · 2025 · PMID 41037744 · DOI 10.1097/asw.0000000000000368