- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05852236
The Effect of Pressure Wound Care Package on the Development of Operating Room Pressure Wound in Orthopedic Surgery
The Effect of Pressure Wound Care Package on O.R. Pressure Wound Development
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey, 27500
- Şehitkamil Devlet Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
The standard care of the clinic was applied to the control group.
|
Pressure ulcer care package application.
|
|
Experimental: Study Group
The pressure ulcer care package developed for this study was applied to the study group.
|
Pressure ulcer care package application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of pressure ulcer care package on the incidence of pressure ulcers in patients
Time Frame: Implementation Time: 3.5 Month
|
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.
|
Implementation Time: 3.5 Month
|
|
The effect of pressure ulcer care package on pain perception in patients
Time Frame: Implementation Time: 3.5 Month
|
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. |
Implementation Time: 3.5 Month
|
|
The effect of pressure ulcer care package on fear of falling in patients
Time Frame: Implementation Time: 3.5 Month
|
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. |
Implementation Time: 3.5 Month
|
|
The effect of pressure ulcer care package on comfort in patients
Time Frame: Implementation Time: 3.5 Month
|
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. |
Implementation Time: 3.5 Month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ayla YAVA, PhD, Prefessor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ŞehitkamilDH275002727
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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