NCT06974552

The Effect of Different Support Surface Applications

The Effect of Different Support Surface Applications on Pressure Injury and Pain in Patients Undergoing Robotic Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

Safe and procedure-specific patient positioning is a critical component of successful surgical outcomes. In robotic surgeries, particularly those involving the lower pelvic region, the steep Trendelenburg position is frequently used to optimize surgical exposure. However, as the angle of the Trendelenburg position increases and the patient remains in this posture for a prolonged period, the risk of adverse events such as nerve injuries, pressure injuries, and deep tissue ischemia also increases. Unlike traditional surgeries where repositioning the patient may be possible during the procedure, robotic surgeries do not allow for intraoperative repositioning due to the fixed docking of robotic arms. Consequently, safe and effective positioning strategies are essential to prevent patient movement and minimize the risk of skin and soft tissue damage. The current systems used for managing patients in the steep Trendelenburg position are suboptimal. There is limited evidence in the literature regarding the incidence and prevention of pressure injuries associated with this specific position during robotic surgery. Prolonged immobility in this posture increases friction and pressure at contact surfaces, which can lead to pressure-related injuries. The use of appropriate support surfaces is therefore vital to reduce the risk of such injuries. This study aims to address this gap by evaluating and comparing different support surfaces placed under the shoulders during robotic surgery in the steep Trendelenburg position, with a focus on their effects on pressure injury development and postoperative pain. Hypotheses of the study H1: The use of microbead-filled support surfaces under the shoulders is superior to gel support surfaces in preventing pressure injuries and pain. H2: The use of gel support surfaces under the shoulders is superior to microbead-filled support surfaces in preventing pressure injuries and pain.

Conditions

• Pressure Incidence Prevention
• Pain

Interventions

Type	Name	Description
PROCEDURE	microbead-filled support surfaces	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.
PROCEDURE	Jel support surfaces	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.

Timeline

• Start date: 2025-05-08
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

1 site across 1 country: Turkey (Türkiye)