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

March 15, 2024 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Taoyuan Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intervention A
full bed silicone mattress plus other measures
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
No Intervention: intervention B
full bed silicone mattress plus usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the occurrence of surgery-related pressure injuries
Time Frame: baseline, pre-surgery; every two hours during the surgery till ten hours; and post-surgery to the 2nd day after surgeryl
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Director: Mei-Chu Tsai, MN, Nursing Department of Taoyuan Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202100409A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on full bed silicone mattress plus other measures

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe