Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing … (NCT06615271) | Clinical Trial Compass
RecruitingNot Applicable
Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.
Spain170 participantsStarted 2023-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: 72 hours
Trial details
NCT IDNCT06615271
SponsorInstituto de Investigación Marqués de Valdecilla