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

Primary Purpose

Pressure Ulcer, Cardiac Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
3D spacer Fabric Based Mattress
Sponsored by
İsmail TOYGAR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pressure Ulcer focused on measuring Pressure ulcer, Operating room, Cardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Şehit Prof. Dr. İlhan Varank Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

3D Spacer Mattress

Operating Room Mattress

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pressure level
Pressure between the product surface and patients' body

Secondary Outcome Measures

Full Information

First Posted
September 23, 2023
Last Updated
October 2, 2023
Sponsor
İsmail TOYGAR
Collaborators
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT06071039
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
September 22, 2023 (Actual)
Study Completion Date
September 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
İsmail TOYGAR
Collaborators
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Cardiac Surgery
Keywords
Pressure ulcer, Operating room, Cardiac Surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D Spacer Mattress
Arm Type
Experimental
Arm Description
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.
Arm Title
Operating Room Mattress
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
3D spacer Fabric Based Mattress
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pressure level
Description
Pressure between the product surface and patients' body
Time Frame
through study completion, an average of 1 yea

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ismail toyğar, Ph.D.
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Şehit Prof. Dr. İlhan Varank Education and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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