Clinical trial NCT06316726: The Effectiveness of Two Nursing Programs on the Surgery-related Pressure Injury
Official title: The Effectiveness of Two Nursing Programs on the Surgery-Related Pressure Injury in Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Surgery
Keywords: surgery-related pressure injury
incidence
grade
sites
time
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 461
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: the occurrence of surgery-related pressure injuries
timeFrame: baseline, pre-surgery; every two hours during the surgery till ten hours; and post-surgery to the 2nd day after surgeryl
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
Study officials:
affiliation: Nursing Department of Taoyuan Chang Gung Memorial Hospital
name: Mei-Chu Tsai, MN
role: STUDY_DIRECTOR
References:
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