Clinical trial NCT05549830: Effect of Different Positioning Before, During and After Surgery on Pressure Injury
Official title: The Effect of Different Positioning Before, During and After Surgery on Pressure Injury: a Randomized Controlled Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Injury
Injuries
Keywords: Surgical pressure injury
Prevention
Patient positioning
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this trial, a two-group design will be used, with an equal number of random participants assigned to each group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Patients undergoing surgery are at risk of developing pressure injuries since they remain in a fixed position on the operating table under anesthesia for a long time. In the management of surgical patients, the prevention of surgical pressure injuries is the best strategy, requiring effective risk assessment and timely implementation of preventive interventions.

Aim: To evaluate the effect of preoperative and postoperative patient repositioning other than intraoperative positions on the development of pressure injuries.

H1 Hypothesis: In the preoperative and postoperative periods, there is a significant difference in the development of pressure injuries between patients who have been repositioned using non-surgical positions compared to those that did not undergo this intervention.

Methods: This study has been designed as a prospective randomized controlled trial. Patients meeting the inclusion criteria of the trial will be allocated to the intervention and control groups using a random number generator. The participants to be assigned to the intervention group will be placed in different positions other than their surgical positions on the night before surgery and until the first 36 hours after the operation, while the control group will only receive routine care. The groups will be evaluated in terms of pressure injury development for at least 72 hours until the end of the postoperative sixth day or discharge from the hospital.

Detailed description: INTRODUCTION

Surgical interventions constitute one of the many risk factors that cause the development of pressure injuries. Since patients are in an immobile and fixed position during surgery and under the effect of anesthetic agents, they cannot feel the pain caused by pressure and shear forces or change their positions.Therefore, all patients undergoing surgical interventions are at risk of developing pressure injuries.

Surgical pressure injuries are those that occur during surgery or within the first 72 hours or first six days after surgery, and they are considered to be important complications that can have undesirable consequences. The development of surgical pressure injuries not only increases postoperative recovery time and length of hospital stay but also results in additional treatment requirement and pain experience for the patient, have adverse physical, mental, and financial effects, poses a risk of infection, and leads to reduced quality of life and deformities. In addition, the perioperative development of these injuries is an important indicator of the quality of care in terms of both the patient and the healthcare center and a serious safety issue for the former.

Despite technological advances, surgical pressure injuries remain a clinical problem for patients undergoing surgery. According to national and international studies, the prevalence of these injuries ranges from 0.3% to 66%, accounting for 4% to 45% of all hospital-acquired pressure injuries and shows an increasing trend in recent years. Among the risky surgical interventions listed in the literature are cardiac, general (abdominal and hepatobiliary), orthopedic, neurosurgical, vascular, urological, and thoracic operations.

The best strategy to manage pressure injuries is prevention rather than treatment. In this regard, it is recommended to perform an effective risk assessment and implement timely preventive interventions. The primary step is risk assessment, including the evaluation of associated risk factors and a comprehensive examination of skin condition, which helps identify high-risk cases in which to implement preventive interventions. Although many risk factors have been reported to contribute to the development of pressure injuries in patients undergoing surgery, the most important evidence-based risk factors have been shown to be preoperative immobility time, operation time, intraoperative hypothermia and hypotension, and immobility on the first postoperative day (level of evidence: weak; strength of recommendation: strong). Recommendations for prevention include patient positioning in a way to reduce the risk of pressure injury development during surgery (level of evidence: weak; strength of recommendation: strong), use of pressure support surfaces on the operating table (level of evidence: strong; strength of recommendation: weak), and redistribution of pressure before and after surgery (level of evidence: weak; strength of recommendation: strong). It is recommended that patients should be placed in different positions before and after surgery to redistribute pressure. However, there are a limited number of studies in the literature investigating the effectiveness of this application, which is based on a weak level of evidence but a strong recommendation, and it is emphasized that there is a need for further studies focusing on post-anesthesia nursing care and standards in practice.

Patient positioning plays a key role in the prevention of pressure injuries, and repositioning is recommended in all patients at risk of developing these injuries unless contraindicated (level of evidence: strong; strength of recommendation: strong). Patient repositioning aims to reduce the duration and size of pressure over bony prominences and increase the duration of the resistance of tissues. This is a cost-free, non-invasive, and effective method of redistributing pressure. In a study investigating the effect of a postoperative care bundle that included placing the patient in different positions other than those used during surgery, prophylactic dressing applied at pressure points, and use of an intraoperative pressure support surface, it was reported that the incidence of pressure injuries in the patients was completely eliminated at the end of the second year.

Considering the suggestion that placing the patient in a position different from surgical positions as long as possible will help distribute the pressure to other pressure points, thus shortening the length of time during which the tissue is at risk and reducing the risk of developing pressure injuries, we have designed the current study to investigate the effects of preoperatively and postoperatively repositioning patients on the development of pressure injuries.

METHODS

Trial design:

In this trial, a two-group design will be used, with an equal number of random participants assigned to each group.

Setting:

The trial will be carried out at the general surgery clinic and intensive care unit (ICU) of a training and research hospital in Bursa, Turkey.

Participants and sampling:

The sample of the study was determined with the power analysis using G\*Power 3 (2007) software. Based on the pressure injury rates reported on the first postoperative day for the patient groups included in the study of Guo et al. (17.65% in the control group, 0% in the intervention group), the effect size (d) was calculated as 0.31 to achieve a statistical test power (1-β) of 80% at a type I error (α) of 0.05, and taking into account the standard deviation value, the minimum number of participants to be included in the sample was determined as 88 (44 for each group). However, we decided to include a total of 100 patients (50 in the intervention group and 50 in the control group) in order to prevent a decrease in test power due to the possibility of data loss during data collection.

Randomization:

The participants will be determined from the surgery list, and those meeting the inclusion criteria will be randomly assigned to either group using a random number generator (https://www.randomizer.org).

Instruments:

Study data will be collected using an individual and clinical characteristics form, the Munro Pressure Ulcer Risk Assessment Scale (Munro scale), the Patient Mobility and Observer Mobility Scale, a pressure injury diagnosis and staging form, and a patient follow-up form.

Ethical considerations:

For the collection of study data, ethical approval was obtained from the Clinical Research Ethics Committee of Uludag University Faculty of Medicine (decision number: 2022-4/36, date: 23.02.2022) and written permission from the institution where the study will be conducted. In addition, for the scales to be used in the study, written permission was received from the authors who performed their validity and reliability analyses in Turkey. During the data collection process, informed voluntary verbal and written consent will be obtained from all the participants after explaining the purpose of the research, study procedure, and their rights in this process. Throughout the study, we will follow the principles of the Declaration of Helsinki 2008 and Good Clinical Practice.

Eligibility criteria: Inclusion Criteria:

* Being scheduled to undergo elective major abdominal surgery that is expected to take three or more hours,
* Being aged 18 years or older,
* Having no communication problems,
* Being able to communicate in Turkish,
* Being conscious and having intact orientation function, i.e., awareness of place, person, and time,
* Providing written informed consent to participate in the study.

Exclusion Criteria:

* Being planned to undergo emergency major abdominal surgery,
* Having preoperative pressure injuries.

Exclusion Criteria to be Applied After the İnitiation of the Study:

* Defined as developing a contraindicated condition during postoperative positioning,
* Being discharged within the first 72 hours postoperatively.

Primary outcomes:
measure: Surgical pressure injury development
timeFrame: From at least 72 hours after surgery until the sixth postoperative day or discharge from the hospital if earlier.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, Institute of Health Sciences
state: Maltepe
Study officials:
affiliation: Marmara University, Institute of Health Sciences
name: Bedia Güler, Nurse
role: PRINCIPAL_INVESTIGATOR
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