Clinical trial NCT06071039: Development of a 3D Spacer Mattress for Pressure Relieving in Cardiac Surgery and Evaluation of Its Efficacy
Official title: Development of a 3D Spacer Mattress for Pressure Relieving in Cardiac Surgery and Evaluation of Its Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Cardiac Surgery
Keywords: Pressure ulcer
Operating room
Cardiac Surgery
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Bahçeşehir University
First posted: 2023-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pressure level
timeFrame: through study completion, an average of 1 yea
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Şehit Prof. Dr. İlhan Varank Education and Research Hospital
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: ismail toyğar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: