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

NCT06071039 | Completed

• 1 other identifier: Bahcesehir
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer; Cardiac Surgery

Keywords

Pressure ulcer; Operating room; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Pressure level

  Pressure between the product surface and patients' body

  through study completion, an average of 1 yea

Study Arms (2)

3D Spacer Mattress

EXPERIMENTAL

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

Operating Room Mattress

NO INTERVENTION

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.

Interventions

3D spacer Fabric Based Mattress COMBINATION_PRODUCT

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.

3D Spacer Mattress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years or older
• Not having a pressure ulcer prior to surgery
• Agreeing to participate in the study

You may not qualify if:

• \- Not agreeing to participate in the study.

Sponsors & Collaborators

• İsmail TOYGAR: lead
• Bahçeşehir University: collaborator

Study Sites (1)

Şehit Prof. Dr. İlhan Varank Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Isler Isildak Y, Eti Aslan F, Korkmaz E, Comez L, Toygar I. Development of a Three-dimensional Spacer Mattress for Pressure Relief in Cardiac Surgery and Evaluation of Its Efficacy: A Feasibility Study. Adv Skin Wound Care. 2025 Nov-Dec 01;38(10):547-555. doi: 10.1097/ASW.0000000000000368. Epub 2025 Sep 30.

  PMID: 41037744 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ismail toyğar, Ph.D.

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: October 6, 2023
• Study Start: February 1, 2023
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)