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The Effect of Pressure Wound Care Package on the Development of Operating Room Pressure Wound in Orthopedic Surgery

Primary Purpose

Pressure Injury, Orthopedic Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Assigned Interventions
Sponsored by
Sehitkamil Devlet Hastanesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pressure Injury focused on measuring orthopedic surgery, pressure injury, care bundle, pain, fear of falling, comfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 years of age or older Orthopaedics and traumatology department Those who have undergone general or spinal anaesthesia No history of surgery in the last month Without any communication problems 3S Patients with a score of 18 and above on the Operating Theatre Pressure Wound Risk Assessment Scale Patients admitted to the emergency clinic, whose trauma-related surgery is planned within 24 hours from the emergency clinic Admission to the orthopaedics and traumatology clinic within maximum 24 hours from the day of surgery planned as elective surgery Patients who volunteered to participate in the study were included. Exclusion Criteria: I'm the one whose surgery was cancelled Those who have undergone local or regional anaesthesia Patients referred to the intensive care unit after surgery Patients who wanted to leave the study after volunteering were excluded from the study.

Sites / Locations

  • Şehitkamil Devlet Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Group

Study Group

Arm Description

The standard care of the clinic was applied to the control group.

The pressure ulcer care package developed for this study was applied to the study group.

Outcomes

Primary Outcome Measures

The effect of pressure ulcer care package on the incidence of pressure ulcers in patients
In this study, it was seen that the pressure ulcer care package applied to the study group contributed positively to the change in the incidence rate of pressure ulcers.
The effect of pressure ulcer care package on pain perception in patients
In this study, it was seen that the pressure ulcer care package applied to the study group made positive contributions to the change of pain level. Visual Analog Scale was used to evaluate the level of pain. The score obtained from the scale ranges from one to ten. The higher the score, the higher the level of pain.
The effect of pressure ulcer care package on fear of falling in patients
In this study, the pressure ulcer care package applied to the study group changed the fear of falling in patients. Visual Analogue Scale was used to obtain numerical data in the assessment of fear of falling. The score obtained from the scale ranges from one to ten. The higher the score, the greater the fear of falling.
The effect of pressure ulcer care package on comfort in patients
In this study, the pressure ulcer care package applied to the study group changed the comfort of the patients. The comfort level of the patients was determined by using the short form of the comfort scale. As the score obtained from the scale increases, the level of comfort increases.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2023
Last Updated
May 1, 2023
Sponsor
Sehitkamil Devlet Hastanesi
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1. Study Identification

Unique Protocol Identification Number
NCT05852236
Brief Title
The Effect of Pressure Wound Care Package on the Development of Operating Room Pressure Wound in Orthopedic Surgery
Official Title
The Effect of Pressure Wound Care Package on O.R. Pressure Wound Development
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 16, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sehitkamil Devlet Hastanesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
SUMMARY In a non-randomised (quasi-experimental) clinical study, it was aimed to determine the effect of the care package applied in the early postoperative period on operating theatre pressure sores, pain, fear of falling and comfort in patients undergoing orthopaedic surgery. In the study, the care bundle for pressure injuries was prepared in accordance with the clinical guidelines and was applied to the patients in the study group. This study was conducted in the orthopaedics and traumatology clinic of a public hospital in the Southeastern Anatolia Region of Turkey.
Detailed Description
Medhod:Patients in the control group underwent routine practice of the clinic and this group was observed for 199 days. The care bundle for pressure injuries developed within the scope of the research was not applied. In the study group, in addition to routine clinical practice, the care bundle for pressure injuries developed for this study was applied for 105 days. Since the pressure ulcer originating from the operating room was seen until the 48th-72nd hour, the evaluations and interventions within the scope of the study were performed for three days, considering the operation day as the zeroth day for the control and study groups. A total of 190 patients, 122 in the control group and 68 in the study group, were included in the study. The care bundle consisted of "skin care, positioning, early mobilization, nutrition, and fluid intake" interventions. In the study, first, the data of the control group and then the data of the study group were collected. Data Collection Tools: The Patient Descriptive Information Form consists of sociodemographic data. The 3S OR Pressure Injury Risk Assessment Scale was used to identify patients at risk of developing OR pressure ulcers. Visual Analogue Scale was used to evaluate pain perception. The Visual Analog Scale was used to determine the fear of falling. General Comfort Questionnaire-Short Form was used to determine the comfort level. The National Pressure Ulcer Advisory Panel (NPUAP) 2016 Pressure Injury Staging System was used to assess and stage pressure ulcer development. Pressure Injury Areas and Stages Follow-up Registration Form; The form in which the pressure ulcer development status is recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury, Orthopedic Surgery
Keywords
orthopedic surgery, pressure injury, care bundle, pain, fear of falling, comfort

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Masking Description
Non-Randomized
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
The standard care of the clinic was applied to the control group.
Arm Title
Study Group
Arm Type
Experimental
Arm Description
The pressure ulcer care package developed for this study was applied to the study group.
Intervention Type
Other
Intervention Name(s)
Assigned Interventions
Intervention Description
Pressure ulcer care package application.
Primary Outcome Measure Information:
Title
The effect of pressure ulcer care package on the incidence of pressure ulcers in patients
Description
In this study, it was seen that the pressure ulcer care package applied to the study group contributed positively to the change in the incidence rate of pressure ulcers.
Time Frame
Implementation Time: 3.5 Month
Title
The effect of pressure ulcer care package on pain perception in patients
Description
In this study, it was seen that the pressure ulcer care package applied to the study group made positive contributions to the change of pain level. Visual Analog Scale was used to evaluate the level of pain. The score obtained from the scale ranges from one to ten. The higher the score, the higher the level of pain.
Time Frame
Implementation Time: 3.5 Month
Title
The effect of pressure ulcer care package on fear of falling in patients
Description
In this study, the pressure ulcer care package applied to the study group changed the fear of falling in patients. Visual Analogue Scale was used to obtain numerical data in the assessment of fear of falling. The score obtained from the scale ranges from one to ten. The higher the score, the greater the fear of falling.
Time Frame
Implementation Time: 3.5 Month
Title
The effect of pressure ulcer care package on comfort in patients
Description
In this study, the pressure ulcer care package applied to the study group changed the comfort of the patients. The comfort level of the patients was determined by using the short form of the comfort scale. As the score obtained from the scale increases, the level of comfort increases.
Time Frame
Implementation Time: 3.5 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Orthopaedics and traumatology department Those who have undergone general or spinal anaesthesia No history of surgery in the last month Without any communication problems 3S Patients with a score of 18 and above on the Operating Theatre Pressure Wound Risk Assessment Scale Patients admitted to the emergency clinic, whose trauma-related surgery is planned within 24 hours from the emergency clinic Admission to the orthopaedics and traumatology clinic within maximum 24 hours from the day of surgery planned as elective surgery Patients who volunteered to participate in the study were included. Exclusion Criteria: I'm the one whose surgery was cancelled Those who have undergone local or regional anaesthesia Patients referred to the intensive care unit after surgery Patients who wanted to leave the study after volunteering were excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayla YAVA, PhD
Organizational Affiliation
Prefessor
Official's Role
Study Director
Facility Information:
Facility Name
Şehitkamil Devlet Hastanesi
City
Gaziantep
ZIP/Postal Code
27500
Country
Turkey

12. IPD Sharing Statement

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The Effect of Pressure Wound Care Package on the Development of Operating Room Pressure Wound in Orthopedic Surgery

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