Clinical trial

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

Name

202100409A3

Description

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.

Trial arms

Trial start

2021-12-15

Estimated PCD

2023-08-31

Trial end

2023-08-31

Status

Completed

Treatment

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

Arms:

intervention A

Size

461

Primary endpoint

the occurrence 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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 461, 'type': 'ACTUAL'}}

Updated at

2024-03-18

1 organization

1 product

2 indications

Organization

Chang Gung Memorial Hospital

Product

Full Bed Silicone Mattress

Indication

Pressure Injury

Indication

Surgery