Pressure Incidence PreventionNCT06974552
The Effect of Different Support Surface Applications
A study testing microbead-filled support surfaces and Jel support surfaces in people with Pressure Incidence Prevention and Pain, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pressure Incidence Prevention, Pain
- What is being tested?
- microbead-filled support surfaces and Jel support surfaces
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to undergo robotic surgery in the lower pelvic region in the steep Trendelenburg position
- Patients aged 18 years and older
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University
Istanbul, Ataşehir, 34750
Mehtap Adıgüzel Akbaba, MSc. RN. PhD student, +905548861601, guzel.nisan@gmail.com
Ukke Karabacak, Prof, 0902165004160, ukke.karabacak@acibadem.edu.tr
About this study
Official title: The Effect of Different Support Surface Applications on Pressure Injury and Pain in Patients Undergoing Robotic Surgery
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.
Read the 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
- Being tested
- microbead-filled support surfaces, Jel support surfaces
- Keywords
- pressure injury, robotic surgery, deep trendelenburg position, pain
- Medical subject headings
- Pain, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbead-filled support surfacesProcedure or surgery
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.
Jel support surfacesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Jel support surfaces |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start8 May 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pressure Incidence PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ukke Karabacak, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974552
- Sponsor's protocol ID
- ATADEK-2025/06
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Safe Practices When Positioning Patients in the Trendelenburg Position. AORN J. 2024 May;119(5):P9. doi: 10.1002/aorn.14134. No abstract available.
PubMed 38661435Celik 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.
PubMed 31246295Engels 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.
PubMed 26924365Chen 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.
PubMed 37898108
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Support Surface Applications on Pressure Injury and Pain in Patients Undergoing Robotic Surgery
- ClinicalTrials.gov ID
- NCT06974552
- Acronym / sponsor ID
- ATADEK-2025/06
- Conditions
- Pressure Incidence Prevention, Pain
- Keywords
- pressure injury, robotic surgery, deep trendelenburg position, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Microbead-Filled Support Surface) | Experimental | Procedure: microbead-filled support surfacesPatients undergoing robotic surgery in the deep Trendelenburg position who received microbead-filled support surfaces applied to the shoulder areas. |
| Control Group (gel support surfaces ) | Other | Procedure: Jel support surfacesPatients undergoing robotic surgery in the deep Trendelenburg position who received gel support surfaces applied to the shoulder areas. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo robotic surgery in the lower pelvic region in the steep Trendelenburg position
- Patients aged 18 years and older
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microbead-filled support surfacesPatients 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 or surgery | Experimental Group (Microbead-Filled Support Surface) |
| Jel support surfacesPatients 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. | Procedure or surgery | Control Group (gel support surfaces ) |
Primary outcome
Change in the pressure injury condition
Time frame: 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.
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)
Change in the pain level
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Results publication: PubMed 38661435Safe Practices When Positioning Patients in the Trendelenburg Position. AORN J. 2024 May;119(5):P9. doi: 10.1002/aorn.14134. No abstract available.
- Results publication: PubMed 31246295Celik 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.
- Results publication: PubMed 26924365Engels 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.
- Results publication: PubMed 37898108Chen 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.
- Individual participant dataSharing planned: No
Related trials for Pressure Incidence Prevention
Enrolling by invitationObservational study
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
Pressure Injury Prevention
Not yet recruiting
Combined Strategy Using Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring to Prevent Microaspiration: a Multicenter Randomized Controlled Trial.
Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microbead-filled support surfaces and Jel support surfaces in people with Pressure Incidence Prevention and Pain, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ukke Karabacak, Prof (0902165004160, ukke.karabacak@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the pressure injury condition (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974552, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.