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

Surgery Clinical Trial

Official title:

The Effectiveness of Two Nursing Programs on the Surgery-Related Pressure Injury in Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06316726
• Other study ID #: 202100409A3
• Status: Completed
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 20 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

Exclusion Criteria:

• Those whose skin is red, swollen, hot, painful, redness, rash, purple spots, bruising, scaly skin, damaged, etc.

• Refuse to participate in the study

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Pressure Ulcer
• Surgery
• Wounds and Injuries

Intervention

Combination Product:
• full bed silicone mattress plus other measures
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

Locations

Country	Name	City	State
Taiwan	Taoyuan Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Via — View Citation

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):19 — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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