The Effect of Different Support Surface Applications

Acibadem University

Status: Enrolling

Conditions: Pressure Incidence Prevention; Pain

Treatments: Procedure: Jel support surfaces; Procedure: microbead-filled support surfaces

Study type: Interventional

Funder types: Other

Identifiers

NCT06974552

ATADEK-2025/06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Experimental Group (Microbead-Filled Support Surface)

Experimental group

Description:

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

Treatment:

Procedure: microbead-filled support surfaces

Control Group (gel support surfaces )

Other group

Description:

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

Treatment:

Procedure: Jel support surfaces