Pressure InjuryNCT05549830
Effect of Different Positioning Before, During and After Surgery on Pressure Injury
A study testing Patient Positioning in people with Pressure Injury and Injuries, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury, Injuries
- What is being tested?
- Patient Positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Institute of Health Sciences
Istanbul, Maltepe, 34854
About this study
Official title: The Effect of Different Positioning Before, During and After Surgery on Pressure Injury: a Randomized Controlled Study Protocol
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.
Read more
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.
Read the 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.
- Conditions
- Pressure Injury, Injuries
- Being tested
- Patient Positioning
- Keywords
- Surgical pressure injury, Prevention, Patient positioning
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient PositioningOther
Also called Place the patient in a different position compared to during surgery, In the preoperative and postoperative periods.
In the preoperative period, the patient/patient relative will be informed about the possible surgical position and the importance of placing the patient in a different position before and after surgery.
İn the postoperative period, the patient will be placed in a different position compared to during surgery, with repositioning being undertaken every two hours until the first 36th postoperative hour, and the development of pressure injuries will be evaluated at the 36th hour. If no pressure injury has developed in this period, the patient will be placed in the surgical position for a duration that will not exceed 30 minutes, and then repositioning will be applied at two-hour intervals. If pressure injuries have developed, different repositioning techniques will continue to be applied at two-hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | During the night before surgery and for the first 36 hours after surgery, the participants assigned to the intervention group will be placed in positions different from surgical positions.
After surgery the patient will be placed in a different position compared to during surgery, with repositioning being undertaken every two hours until the first 36th postoperative hour, and the development of pressure injuries will be evaluated at the 36th hour. If no pressure injury has developed in this period, the patient will be placed in the surgical position for a duration that will not exceed 30 minutes, and then repositioning will be applied at two-hour intervals. If pressure injuries have developed, different repositioning techniques will continue to be applied at two-hour intervals. Receives: Other: Patient Positioning |
| Control Group | No intervention | The control group will only receive routine care. The positions of the patients in this group will be monitored and recorded at two-hour intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical pressure injury development
Surgical pressure injuries will be assessed in six categories: stage I, non-blanchable erythema; stage II, partial-thickness skin loss; stage III, full-thickness skin loss; stage IV, full-thickness tissue loss; unstageable, depth unknown; and suspected deep tissue injury, depth unknown, according to the international classification system included in the "Prevention and Treatment of Pressure Ulcers: Quick reference Guide, 2014" published by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance (NPUAP/EPUAP/PPPIA).
Measured: From at least 72 hours after surgery until the sixth postoperative day or discharge from the hospital if earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this trial, a two-group design will be used, with an equal number of random participants assigned to each group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bedia Güler, Nurse, Principal investigator, Marmara University, Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549830
- Sponsor's protocol ID
- MarmaraU_bedia_guler
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walton-Geer PS. Prevention of pressure ulcers in the surgical patient. AORN J. 2009 Mar;89(3):538-48; quiz 549-51. doi: 10.1016/j.aorn.2008.12.022.
PubMed 19269379National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance (NPUAP/EPUAP/PPPIA). Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Perth, Australia; 2014.
Shafipour V, Ramezanpour E, Gorji MA, Moosazadeh M. Prevalence of postoperative pressure ulcer: A systematic review and meta-analysis. Electron Physician. 2016 Nov 25;8(11):3170-3176. doi: 10.19082/3170. eCollection 2016 Nov.
PubMed 28070249Peixoto CA, Ferreira MBG, Felix MMDS, Pires PDS, Barichello E, Barbosa MH. Risk assessment for perioperative pressure injuries. Rev Lat Am Enfermagem. 2019 Jan 17;27:e3117. doi: 10.1590/1518-8345.2677-3117.
PubMed 30698218Spruce L. Back to Basics: Preventing Perioperative Pressure Injuries. AORN J. 2017 Jan;105(1):92-99. doi: 10.1016/j.aorn.2016.10.018.
PubMed 28034406Primiano M, Friend M, McClure C, Nardi S, Fix L, Schafer M, Savochka K, McNett M. Pressure ulcer prevalence and risk factors during prolonged surgical procedures. AORN J. 2011 Dec;94(6):555-66. doi: 10.1016/j.aorn.2011.03.014.
PubMed 22118201Munro CA. The development of a pressure ulcer risk-assessment scale for perioperative patients. AORN J. 2010 Sep;92(3):272-87. doi: 10.1016/j.aorn.2009.09.035.
PubMed 20816101Kandemir D, Yüksel S. Effective evidence-based interventions in preventing surgical pressure injuries. Journal of Hacettepe University Faculty of Nursing. 2021;8(1):85-92.
Buso FD, Ferreira MB, Felix MM, Galvão CM, Barichello E, Barbosa MH. Pressure injury related to surgical positioning and associated factors. Acta Paul Enferm. 2021;34:eAPE00642.
Ramezanpour E, Emami ZA, Heidari MA, Yazdani CJ, Moosazadeh M, Shafipour V. Incidence and risk factors of pressure ulcers among general surgery patients. Journal of Nursing and Midwifery Sciences. 2018;5(4 ).
Kim JM, Lee H, Ha T, Na S. Perioperative factors associated with pressure ulcer development after major surgery. Korean J Anesthesiol. 2018 Feb;71(1):48-56. doi: 10.4097/kjae.2018.71.1.48. Epub 2017 Jul 4.
PubMed 29441175Chen Y, He L, Qu W, Zhang C. Predictors of Intraoperative Pressure Injury in Patients Undergoing Major Hepatobiliary Surgery. J Wound Ostomy Continence Nurs. 2017 Sep/Oct;44(5):445-449. doi: 10.1097/WON.0000000000000356.
PubMed 28877110Shaw LF, Chang PC, Lee JF, Kung HY, Tung TH. Incidence and predicted risk factors of pressure ulcers in surgical patients: experience at a medical center in Taipei, Taiwan. Biomed Res Int. 2014;2014:416896. doi: 10.1155/2014/416896. Epub 2014 Jun 26.
PubMed 25057484Guo Y, Zhao K, Zhao T, Li Y, Yu Y, Kuang W. The effectiveness of curvilinear supine position on the incidence of pressure injuries and interface pressure among surgical patients. J Tissue Viability. 2019 May;28(2):81-86. doi: 10.1016/j.jtv.2019.02.005. Epub 2019 Feb 25.
PubMed 30878174Akan C, Sayın YY. Prevalence of pressure injuries and risk factors in long-term surgical procedures. Bezmialem Science. 2021;9(1):75-83
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Positioning Before, During and After Surgery on Pressure Injury: a Randomized Controlled Study Protocol
- ClinicalTrials.gov ID
- NCT05549830
- Acronym / sponsor ID
- MarmaraU_bedia_guler
- Conditions
- Pressure Injury, Injuries
- Keywords
- Surgical pressure injury, Prevention, Patient positioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Sep 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this trial, a two-group design will be used, with an equal number of random participants assigned to each group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Patient PositioningDuring the night before surgery and for the first 36 hours after surgery, the participants assigned to the intervention group will be placed in positions different from surgical positions. After surgery the patient will be placed in a different position compared to during surgery, with repositioning being undertaken every two hours until the first 36th postoperative hour, and the development of pressure injuries will be evaluated at the 36th hour. If no pressure injury has developed in this period, the patient will be placed in the surgical position for a duration that will not exceed 30 minutes, and then repositioning will be applied at two-hour intervals. If pressure injuries have developed, different repositioning techniques will continue to be applied at two-hour intervals. |
| Control Group | No intervention | –The control group will only receive routine care. The positions of the patients in this group will be monitored and recorded at two-hour intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- Being planned to undergo emergency major abdominal surgery,
- Having preoperative pressure injuries.
- Defined as developing a contraindicated condition during postoperative positioning,
- Being discharged within the first 72 hours postoperatively.
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 |
|---|---|---|
| Patient PositioningAlso: Place the patient in a different position compared to during surgery, In the preoperative and postoperative periods.In the preoperative period, the patient/patient relative will be informed about the possible surgical position and the importance of placing the patient in a different position before and after surgery. İn the postoperative period, the patient will be placed in a different position compared to during surgery, with repositioning being undertaken every two hours until the first 36th postoperative hour, and the development of pressure injuries will be evaluated at the 36th hour. If no pressure injury has developed in this period, the patient will be placed in the surgical position for a duration that will not exceed 30 minutes, and then repositioning will be applied at two-hour intervals. If pressure injuries have developed, different repositioning techniques will continue to be applied at two-hour intervals. | Other | Intervention Group |
Primary outcome
Surgical pressure injury development
Time frame: From at least 72 hours after surgery until the sixth postoperative day or discharge from the hospital if earlier.
Surgical pressure injuries will be assessed in six categories: stage I, non-blanchable erythema; stage II, partial-thickness skin loss; stage III, full-thickness skin loss; stage IV, full-thickness tissue loss; unstageable, depth unknown; and suspected deep tissue injury, depth unknown, according to the international classification system included in the "Prevention and Treatment of Pressure Ulcers: Quick reference Guide, 2014" published by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance (NPUAP/EPUAP/PPPIA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Background: PubMed 19269379Walton-Geer PS. Prevention of pressure ulcers in the surgical patient. AORN J. 2009 Mar;89(3):538-48; quiz 549-51. doi: 10.1016/j.aorn.2008.12.022.
- BackgroundNational Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance (NPUAP/EPUAP/PPPIA). Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Perth, Australia; 2014.
- Background: PubMed 28070249Shafipour V, Ramezanpour E, Gorji MA, Moosazadeh M. Prevalence of postoperative pressure ulcer: A systematic review and meta-analysis. Electron Physician. 2016 Nov 25;8(11):3170-3176. doi: 10.19082/3170. eCollection 2016 Nov.
- Background: PubMed 30698218Peixoto CA, Ferreira MBG, Felix MMDS, Pires PDS, Barichello E, Barbosa MH. Risk assessment for perioperative pressure injuries. Rev Lat Am Enfermagem. 2019 Jan 17;27:e3117. doi: 10.1590/1518-8345.2677-3117.
- Background: PubMed 28034406Spruce L. Back to Basics: Preventing Perioperative Pressure Injuries. AORN J. 2017 Jan;105(1):92-99. doi: 10.1016/j.aorn.2016.10.018.
- Background: PubMed 22118201Primiano M, Friend M, McClure C, Nardi S, Fix L, Schafer M, Savochka K, McNett M. Pressure ulcer prevalence and risk factors during prolonged surgical procedures. AORN J. 2011 Dec;94(6):555-66. doi: 10.1016/j.aorn.2011.03.014.
- Background: PubMed 20816101Munro CA. The development of a pressure ulcer risk-assessment scale for perioperative patients. AORN J. 2010 Sep;92(3):272-87. doi: 10.1016/j.aorn.2009.09.035.
- BackgroundKandemir D, Yüksel S. Effective evidence-based interventions in preventing surgical pressure injuries. Journal of Hacettepe University Faculty of Nursing. 2021;8(1):85-92.
- BackgroundBuso FD, Ferreira MB, Felix MM, Galvão CM, Barichello E, Barbosa MH. Pressure injury related to surgical positioning and associated factors. Acta Paul Enferm. 2021;34:eAPE00642.
- BackgroundRamezanpour E, Emami ZA, Heidari MA, Yazdani CJ, Moosazadeh M, Shafipour V. Incidence and risk factors of pressure ulcers among general surgery patients. Journal of Nursing and Midwifery Sciences. 2018;5(4 ).
- Background: PubMed 29441175Kim JM, Lee H, Ha T, Na S. Perioperative factors associated with pressure ulcer development after major surgery. Korean J Anesthesiol. 2018 Feb;71(1):48-56. doi: 10.4097/kjae.2018.71.1.48. Epub 2017 Jul 4.
- Background: PubMed 28877110Chen Y, He L, Qu W, Zhang C. Predictors of Intraoperative Pressure Injury in Patients Undergoing Major Hepatobiliary Surgery. J Wound Ostomy Continence Nurs. 2017 Sep/Oct;44(5):445-449. doi: 10.1097/WON.0000000000000356.
- Individual participant dataSharing planned: No
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Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
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. This study is not recruiting at the moment.
Bedia Güler, Nurse principal investigator
Marmara University, Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Positioning in people with Pressure Injury and Injuries, run by Marmara 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 6 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: status not confirmed, as of the sponsor's last update on 22 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bedia Güler, Nurse (+90 536 948 57 30, bedia-guler@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical pressure injury development (time frame: From at least 72 hours after surgery until the sixth postoperative day or discharge from the hospital if earlier.). 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 NCT05549830, which also lists 25 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 22 Sep 2022.