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

NCT ID: NCT06316726

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pressure Injury Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intervention A

full bed silicone mattress plus other measures

Group Type ACTIVE_COMPARATOR

full bed silicone mattress plus other measures

Intervention Type 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 B

full bed silicone mattress plus usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mei-Chu Tsai, MN

Role: STUDY_DIRECTOR

Nursing Department of Taoyuan Chang Gung Memorial Hospital

Locations

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Taoyuan Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 9801935 (View on PubMed)

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.

Reference Type RESULT
PMID: 16422733 (View on PubMed)

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.

Reference Type RESULT
PMID: 16881492 (View on PubMed)

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.

Reference Type RESULT
PMID: 21841719 (View on PubMed)

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.

Reference Type RESULT
PMID: 30517574 (View on PubMed)

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.

Reference Type RESULT
PMID: 30601427 (View on PubMed)

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.

Reference Type RESULT
PMID: 33612359 (View on PubMed)

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.

Reference Type RESULT
PMID: 36782315 (View on PubMed)

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.

Reference Type RESULT
PMID: 25874704 (View on PubMed)

Other Identifiers

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202100409A3

Identifier Type: -

Identifier Source: org_study_id

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