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RecruitingNCT06615271UPSUpdated Sep 26, 2024

Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.

An observational study in PRESSURE INJURIES, sponsored by Instituto de Investigación Marqués de Valdecilla. Recruiting at 2 sites in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-09-26.

Sponsored by Instituto de Investigación Marqués de Valdecilla · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
18 Years to 100 Years
Sex
All
01

Study summary

This research project is a descriptive, longitudinal prospective observational study in the HUMV neurosurgery operating rooms. The patients included will be adults 18 years old or older, who will be scheduled for surgery by the Neurosurgery service. Those who meet the selection criteria determined for this study will be chosen consecutively and will be followed from the immediate preoperative moment until 72 hours after the end of the surgery. Data collection shall be carried out by direct observation and immersion in clinical records of patients who have signed the informed consent. The study will be carried out in 4 phases: immediate preoperative, intraoperative, immediate postoperative and late postoperative, recording the data using various measuring instruments, and a record sheet. Finally, the cumulative incidence of LPPs developed in the perioperative environment will be calculated and a statistical analysis will be performed.

Read the detailed description

The surgical area represents a scenario to be taken into account in the prevention of pressure injuries (LPP), being an essential and priority aspect in these injuries, demonstrating that more than 95% of them are avoidable. The latest national incidence study conducted in 2019, shows an incidence figure of 14% in post-surgical units and resuscitation, approaching the US between 12% and 66% of incidence in surgical patients, being considered a sentinel event, considering a medical cost of more than $26.8 billion.

The project will be developed from June 2023 to May 2025. It has been approved by the Research Ethics Committee of Cantabria, and the start of the study is scheduled for October 2023. Afterwards, the analysis of the data and the interpretation of the results will be done, ending with a final article to be disseminated and disseminated in magazines, congresses or national and international talks.

Surgical patients present specific risk factors, leading to the appearance of LPP. Therefore, this study aims to obtain some initial data to create a clinical care guide and prevention protocols updated and specific for clinical practice.

02

Conditions studied

  • PRESSURE INJURIES

Keywords

  • injuries
  • surgical
  • neurosurgery
  • prevention
  • nurse
  • clinical practice
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's planned enrollment of 170 is above the median of 154 across 97 observational studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Instituto de Investigación Marqués de Valdecilla is the lead sponsor of 32 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adult patients over 18 years, women and men.

Inclusion criteria

  • Patients who understand and sign the informed consent.
  • Adult patients of both sexes who will undergo a schedule surgery of more than 3 hours, by the service of neurosurgery of the University Hospital Marqués of Valdecilla (HUMV), between 2023 and 2024.
  • Patients positioned in prone, supine, lateral and beach chair/sitting.
  • Surgeries susceptible to bladder catheterisation with body temperature measurement.
  • Patients admitted into neurosurgery ward, the day before surgery.

Exclusion criteria

Exclusion Criteria:

  • Patients who do not sign informed consent.
  • Patients with visible pressure injurie present before surgery.
  • Patients with cognitive disorder or written and oral knowledge difficulty.
  • Patients who reject the operation.
  • Patients not operated due to lack of prior time.
  • Patients who do not receive vasoactive drugs such as ephedrine, phenylephrine and noradrenaline.
  • Patients whose postoperative period is performed in the ICU.
  • Patients whose surgical intervention, despite the initial estimate of the surgical time, lasted less than 3 hours.
  • Patients admitted >24 hours prior the surgery.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients who have undergone neurosurgery form more than 3 hours.

    The ones who perform the selection criteria determined for this study will be chosen consecutively, and a follow-up will be carried out from the immediate preoperative moment until 72 hours once the surgery has finished.

    Procedure: Neurosurgery

Interventions

  • ProcedureNeurosurgery

    Patients who have undergone neurosurgery form more than 3 hours.

06

What researchers measure

Primary outcomes

  1. Incidence of pressure injuries in the neurosurgery, in surgical interventions lasting more than 3 hours. It will be measured by direct observation of the wound, from the time the patient enters the operating room until the next 72 hours thereafter.

    Time frame: 72 hours

Secondary outcomes

  1. Locations of the pressure injuries concerning to the different types of positioning.It will be measured by direct observation of the wound, from the time the patient enters the operating room until the next 72 hours thereafter.

    Time frame: 72 hours

  2. the risk factors that contribute to the appearance of pressure injurieS. It will be measured by direct observation of the wound, from the time the patient enters the operating room until the next 72 hours thereafter.

    Time frame: 72 hours

07

Study locations

1 of 2 sites recruiting
  • Hospital Universitario Marques de Valdecilla
    Santander, Cantabria 39008, Spain
    Not yet recruiting
  • Hospital universitario marques de valdecilla
    Santander, 39008, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06615271
Lead sponsor
Instituto de Investigación Marqués de Valdecilla
Responsible party
Sponsor
First posted
Sep 26, 2024
Start date
Dec 1, 2023
Primary completion
Dec 1, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Sep 26, 2024

Study contacts

maria perez sastre
Contact
mariaperezsastre95@gmail.com
+34942203389
Lucía Lavin
Contact
eclinicos5@idival.org
+34942203389

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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