The Effectiveness of Two Nursing Programs on the Surgery-related Pressure Injury

NCT06316726 | Completed DMC

• 1 other identifier: 202100409A3
• Study Type: interventional
• Target: 461
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: This study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions. Methods: This study adopted a true experimental research design with a convenience sampling method from the operating rooms of a teaching hospital in a northern region. The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care). Measurements include basic personal attributes, risk factors, grade, time, and location of occurrence related to surgery-related pressure injuries.

Conditions

Pressure Injury; Surgery

Keywords

surgery-related pressure injury; incidence; grade; sites; time

Outcome Measures

Primary Outcomes (1)

• the occurrence of surgery-related pressure injuries

  incidence, grade, site, and time of surgery-related pressure injuries

  baseline, pre-surgery; every two hours during the surgery till ten hours; and post-surgery to the 2nd day after surgeryl

Study Arms (2)

intervention A

ACTIVE COMPARATOR

full bed silicone mattress plus other measures

Combination Product: full bed silicone mattress plus other measures

intervention B

NO INTERVENTION

full bed silicone mattress plus usual care

Interventions

full bed silicone mattress plus other measures COMBINATION_PRODUCT

full bed silicone mattress plus put silicone pads on the head and shoulders, cotton rolls wraps bony prominence (elbows and heels), petrissage every two hours on shoulders to fingers and lower legs to heels, change location of ankle pads, use round gel full of air sit pad, a pillow on the knees

intervention A

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and more years old
• Over 4 hours lying flat on the operating table (eg., orthognathic surgery, microtia reconstruction surgery, etc.)
• Those who are conscious clearly and can communicate in Mandarin and Taiwanese
• Those with agree to participate in this study

You may not qualify if:

• Those whose skin is red, swollen, hot, painful, redness, rash, purple spots, bruising, scaly skin, damaged, etc.
• Refuse to participate in the study

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (9)

• Nixon J, McElvenny D, Mason S, Brown J, Bond S. A sequential randomised controlled trial comparing a dry visco-elastic polymer pad and standard operating table mattress in the prevention of post-operative pressure sores. Int J Nurs Stud. 1998 Aug;35(4):193-203. doi: 10.1016/s0020-7489(98)00023-6.

  PMID: 9801935 RESULT

• Feuchtinger J, de Bie R, Dassen T, Halfens R. A 4-cm thermoactive viscoelastic foam pad on the operating room table to prevent pressure ulcer during cardiac surgery. J Clin Nurs. 2006 Feb;15(2):162-7. doi: 10.1111/j.1365-2702.2006.01293.x.

  PMID: 16422733 RESULT

• Sewchuk D, Padula C, Osborne E. Prevention and early detection of pressure ulcers in patients undergoing cardiac surgery. AORN J. 2006 Jul;84(1):75-96. doi: 10.1016/s0001-2092(06)60100-2.

  PMID: 16881492 RESULT

• Donnelly J, Winder J, Kernohan WG, Stevenson M. An RCT to determine the effect of a heel elevation device in pressure ulcer prevention post-hip fracture. J Wound Care. 2011 Jul;20(7):309-12, 314-8. doi: 10.12968/jowc.2011.20.7.309.

  PMID: 21841719 RESULT

• Oliveira KF, Pires PDS, De-Mattia AL, Barichello E, Galvao CM, Araujo CA, Barbosa MH. Influence of support surfaces on the distribution of body interface pressure in surgical positioning. Rev Lat Am Enfermagem. 2018 Nov 29;26:e3083. doi: 10.1590/1518-8345.2692.3083.

  PMID: 30517574 RESULT

• Joseph J, McLaughlin D, Darian V, Hayes L, Siddiqui A. Alternating Pressure Overlay for Prevention of Intraoperative Pressure Injury. J Wound Ostomy Continence Nurs. 2019 Jan/Feb;46(1):13-17. doi: 10.1097/WON.0000000000000497.

  PMID: 30601427 RESULT

• Neo TG, Koo SH, Chew STH, Png GK, Lacuesta MJ, Wu MYL, Tay RYC, Singh PA, Chandran R. A randomized controlled trial to compare the interface pressures of alternating pressure overlay with gel pad versus gel pad alone during prolonged surgery. J Tissue Viability. 2021 May;30(2):222-230. doi: 10.1016/j.jtv.2021.02.003. Epub 2021 Feb 6.

  PMID: 33612359 RESULT

• Ahmad B, Rubio-Sefati M, Yacob MM. Incidence and risk factors for pressure injuries in patients who have undergone vascular operations: a scoping review. Eur J Med Res. 2023 Feb 13;28(1):77. doi: 10.1186/s40001-023-01036-3.

  PMID: 36782315 RESULT

• 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 RESULT

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mei-Chu Tsai, MN

  Nursing Department of Taoyuan Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care).

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 18, 2024
• Study Start: December 15, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: March 18, 2024

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)