Pressure InjuryNCT05852236
The Effect of Pressure Wound Care Package on the Development of Operating Room Pressure Wound in Orthopedic Surgery
A study testing Assigned Interventions in people with Pressure Injury and Orthopedic Surgery, run by Sehitkamil Devlet Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Orthopedic Surgery
- What is being tested?
- Assigned Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pressure Wound Care Package on O.R. Pressure Wound Development
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.
Read the 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.
- Conditions
- Pressure Injury, Orthopedic Surgery
- Being tested
- Assigned Interventions
- Keywords
- orthopedic surgery, pressure injury, care bundle, pain, fear of falling, comfort
- Medical subject headings
- Pressure Ulcer, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
Pressure ulcer care package application.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | The standard care of the clinic was applied to the control group. Receives: Other: Assigned Interventions |
| Study Group | Experimental | The pressure ulcer care package developed for this study was applied to the study group. Receives: Other: Assigned Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Implementation Time: 3.5 Month
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.
Measured: Implementation Time: 3.5 Month
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.
Measured: Implementation Time: 3.5 Month
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.
Measured: Implementation Time: 3.5 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jul 2021
- Primary completion16 Jan 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehitkamil Devlet Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Eğilmez, Sehitkamil Devlet Hastanesi
- Investigators
- Ayla YAVA, PhD, Study director, Prefessor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852236
- Sponsor's protocol ID
- ŞehitkamilDH275002727
- Status last verified
- May 2023
- First submitted
- 4 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pressure Wound Care Package on O.R. Pressure Wound Development
- ClinicalTrials.gov ID
- NCT05852236
- Acronym / sponsor ID
- ŞehitkamilDH275002727
- Conditions
- Pressure Injury, Orthopedic Surgery
- Keywords
- orthopedic surgery, pressure injury, care bundle, pain, fear of falling, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Sehitkamil Devlet HastanesiUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 16 Jan 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Assigned InterventionsThe standard care of the clinic was applied to the control group. |
| Study Group | Experimental | Other: Assigned InterventionsThe pressure ulcer care package developed for this study was applied to the study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assigned InterventionsPressure ulcer care package application. | Other | Control Group, Study Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayla YAVA, PhD study director
Prefessor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions in people with Pressure Injury and Orthopedic Surgery, run by Sehitkamil Devlet Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of pressure ulcer care package on the incidence of pressure ulcers in patients (time frame: Implementation Time: 3.5 Month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.