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

• Sponsor: İsmail TOYGAR (Other)
• Overall Status: Completed
• CT.gov ID: NCT06071039
• Collaborator: Bahçeşehir University (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer; Cardiac Surgery	Combination Product: 3D spacer Fabric Based Mattress	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 groupThere 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
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Development of a 3D Spacer Mattress for Pressure Relieving in Cardiac Surgery and Evaluation of Its Efficacy
• Actual Study Start Date: Feb 1, 2023
• Actual Primary Completion Date: Sep 22, 2023
• Actual Study Completion Date: Sep 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D Spacer 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.	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.
No Intervention: Operating Room Mattress For the patients in this group, the mattress which was in common use was used. The mattress used for the patients in this group was made up of foam. The pressure level between the body and the mattress was measured throughout the surgery.

Outcome Measures

Primary Outcome Measures

1. Pressure level [through study completion, an average of 1 yea]

   Pressure between the product surface and patients' body

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Şehit Prof. Dr. İlhan Varank Education and Research Hospital	Istanbul		Turkey

Sponsors and Collaborators

• İsmail TOYGAR
• Bahçeşehir University

Investigators

• Principal Investigator: ismail toyğar, Ph.D., Muğla Sıtkı Koçman University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: İsmail TOYGAR, Associate Professor, Ege University
• ClinicalTrials.gov Identifier: NCT06071039
• Other Study ID Numbers: Bahcesehir
• First Posted: Oct 6, 2023
• Last Update Posted: Oct 6, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by İsmail TOYGAR, Associate Professor, Ege University: Pressure ulcer; Operating room; Cardiac Surgery
• Additional relevant MeSH terms: Pressure Ulcer

Study Results

No Results Posted as of Oct 6, 2023