Effect of Different Positioning Before, During and After Surgery on Pressure Injury

NCT05549830 | Unknown

• 1 other identifier: MarmaraU_bedia_guler
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury; Injuries

Keywords

Surgical pressure injury; Prevention; Patient positioning

Outcome Measures

Primary Outcomes (1)

• 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).

  From at least 72 hours after surgery until the sixth postoperative day or discharge from the hospital if earlier.

Study Arms (2)

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.

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.

Interventions

Patient Positioning OTHER

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.

Also known as: Place the patient in a different position compared to during surgery, In the preoperative and postoperative periods.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, Institute of Health Sciences

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Related Publications (25)

• 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.

  PMID: 19269379 BACKGROUND

• National 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

• 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.

  PMID: 28070249 BACKGROUND

• Peixoto 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.

  PMID: 30698218 BACKGROUND

• Spruce L. Back to Basics: Preventing Perioperative Pressure Injuries. AORN J. 2017 Jan;105(1):92-99. doi: 10.1016/j.aorn.2016.10.018.

  PMID: 28034406 BACKGROUND

• Primiano 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.

  PMID: 22118201 BACKGROUND

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  PMID: 20816101 BACKGROUND

• Kandemir D, Yüksel S. Effective evidence-based interventions in preventing surgical pressure injuries. Journal of Hacettepe University Faculty of Nursing. 2021;8(1):85-92.

  BACKGROUND

• 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.

  BACKGROUND

• 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 ).

  BACKGROUND

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  PMID: 29441175 BACKGROUND

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  PMID: 28877110 BACKGROUND

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  PMID: 25057484 BACKGROUND

• Guo 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.

  PMID: 30878174 BACKGROUND

• Akan C, Sayın YY. Prevalence of pressure injuries and risk factors in long-term surgical procedures. Bezmialem Science. 2021;9(1):75-83

  BACKGROUND

• Karadag M, Gumuskaya N. The incidence of pressure ulcers in surgical patients: a sample hospital in Turkey. J Clin Nurs. 2006 Apr;15(4):413-21. doi: 10.1111/j.1365-2702.2006.01369.x.

  PMID: 16553754 BACKGROUND

• Gurkan A, Kirtil I, Aydin YD, Kutuk G. Pressure injuries in surgical patients: a comparison of Norton, Braden and Waterlow risk assessment scales. J Wound Care. 2022 Feb 2;31(2):170-177. doi: 10.12968/jowc.2022.31.2.170.

  PMID: 35148625 BACKGROUND

• Black J, Fawcett D, Scott S. Ten top tips: preventing pressure ulcers in the surgical patient. Wounds International. 2014;5(4).

  BACKGROUND

• Chen HL, Chen XY, Wu J. The incidence of pressure ulcers in surgical patients of the last 5 years: a systematic review. Wounds. 2012 Sep;24(9):234-41.

  PMID: 25874704 BACKGROUND

• Scott SM. Progress and Challenges in Perioperative Pressure Ulcer Prevention. J Wound Ostomy Continence Nurs. 2015 Sep-Oct;42(5):480-5. doi: 10.1097/WON.0000000000000161. No abstract available.

  PMID: 26336045 BACKGROUND

• Lumbley JL, Ali SA, Tchokouani LS. Retrospective review of predisposing factors for intraoperative pressure ulcer development. J Clin Anesth. 2014 Aug;26(5):368-74. doi: 10.1016/j.jclinane.2014.01.012. Epub 2014 Aug 10.

  PMID: 25113424 BACKGROUND

• Haisley M, Sorensen JA, Sollie M. Postoperative pressure injuries in adults having surgery under general anaesthesia: systematic review of perioperative risk factors. Br J Surg. 2020 Mar;107(4):338-347. doi: 10.1002/bjs.11448. Epub 2020 Jan 21.

  PMID: 31960958 BACKGROUND

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  PMID: 21281759 BACKGROUND

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  PMID: 17695343 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Wounds and Injuries

Interventions

Patient Positioning; Postoperative Period

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Perioperative Period; Surgical Procedures, Operative

Study Officials

• Bedia Güler, Nurse

  Marmara University, Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bedia Güler, Nurse

CONTACT

+90 536 948 57 30; bedia-guler@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will not be used. Participants meeting the inclusion criteria will be assigned to one of the two groups by randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 22, 2022
• Study Start: October 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)