The Effect of Different Support Surface Applications

NCT06974552 | Recruiting

• 1 other identifier: ATADEK-2025/06
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed as a randomized controlled experimental study to compare the effects of two support surfaces-gel pads (used in routine practice) and microbead-filled pads-placed under the shoulders in the steep Trendelenburg position during robotic surgery, on the development of pressure injuries and pain.

Conditions

Pressure Incidence Prevention; Pain

Keywords

pressure injury; robotic surgery; deep trendelenburg position; pain

Outcome Measures

Primary Outcomes (2)

• Change in the pressure injury condition

  The presence or absence of pressure injuries in patients will be assessed. If a pressure injury is present, it will be staged accordingly. Pressure injury assessment will be conducted in accordance with the guidelines of the European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP)

  At the time of admission to the operating room, immediately after surgery, one hour after surgery, 12 hour after surgery, 24 hour after surgery. The change in this time intervals will be assessed.

• Change in the pain level

  The patient's pain will be assessed using the Visual Analog Scale (VAS). VAS is a simple and widely used tool for measuring subjective experiences such as pain. It typically consists of a 10 cm horizontal line, with the left end representing 'no pain' (0) and the right end representing 'worst imaginable pain' (10). The participant is asked to mark the point on the line that best reflects the intensity of their pain.

  Pain will be assessed every 15 minutes during the first two hours after surgery, and then every 30 minutes for the following one hour.The change in this time intervals will be assessed.

Study Arms (2)

Experimental Group (Microbead-Filled Support Surface)

EXPERIMENTAL

Patients undergoing robotic surgery in the deep Trendelenburg position who received microbead-filled support surfaces applied to the shoulder areas.

Procedure: microbead-filled support surfaces

Control Group (gel support surfaces )

OTHER

Patients undergoing robotic surgery in the deep Trendelenburg position who received gel support surfaces applied to the shoulder areas.

Procedure: Jel support surfaces

Interventions

microbead-filled support surfaces PROCEDURE

Patients will undergo a preoperative pressure injury risk assessment. After the induction of general anesthesia, a multilayer silicone wound dressing will be applied to the shoulder area. The shoulder will then be supported using microbead-filled support surfaces. This support surface will remain in place throughout the duration of the surgery.

Experimental Group (Microbead-Filled Support Surface)

Jel support surfaces PROCEDURE

Patients will undergo a preoperative pressure injury risk assessment. After the induction of general anesthesia, a multilayer silicone wound dressing will be applied to the shoulder area. The shoulder will then be supported using jel support surfaces. This support surface will remain in place throughout the duration of the surgery.

Control Group (gel support surfaces )

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo robotic surgery in the lower pelvic region in the steep Trendelenburg position
• Patients aged 18 years and older

You may not qualify if:

• Patients with existing pressure injuries
• Patients with communication barriers
• Patients with skin anomalies that interfere with skin assessment
• Patients requiring conversion to open surgery during the procedure
• Patients whose position is changed during surgery

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem University

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Safe Practices When Positioning Patients in the Trendelenburg Position. AORN J. 2024 May;119(5):P9. doi: 10.1002/aorn.14134. No abstract available.

  PMID: 38661435 BACKGROUND

• Celik B, Karayurt O, Ogce F. The Effect of Selected Risk Factors on Perioperative Pressure Injury Development. AORN J. 2019 Jul;110(1):29-38. doi: 10.1002/aorn.12725.

  PMID: 31246295 BACKGROUND

• Engels D, Austin M, McNichol L, Fencl J, Gupta S, Kazi H. Pressure Ulcers: Factors Contributing to Their Development in the OR. AORN J. 2016 Mar;103(3):271-81. doi: 10.1016/j.aorn.2016.01.008.

  PMID: 26924365 BACKGROUND

• Chen Y, Wang W, Qian Q, Wu B. Comparison of four risk assessment scales in predicting the risk of intraoperative acquired pressure injury in adult surgical patients: a prospective study. J Int Med Res. 2023 Oct;51(10):3000605231207530. doi: 10.1177/03000605231207530.

  PMID: 37898108 BACKGROUND

MeSH Terms

Conditions

Pain; Pressure Ulcer

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ukke Karabacak, Prof

CONTACT

0902165004160; ukke.karabacak@acibadem.edu.tr

Mehtap Adıgüzel Akbaba, MSc. RN. PhD student

CONTACT

+905548861601; guzel.nisan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)