Pressure UlcerNCT06330506
The Effect of Pressure Ulcer Care Package on the Risk of Pressure Ulcer Development
A study testing Pressure ulcer prevention pack in people with Pressure Ulcer, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Pressure ulcer prevention pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 10 Sep 2024
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Orthopaedics and traumatology department
- Those who have undergone general or spinal anesthesia
- Without any communication problems
- Patients who volunteered to participate in the study
Who cannot join
- Patients with pre-operative pressure ulcer
- Those who are bedridden
- Patients referred to the intensive care unit after surgery
- Patients who wish to leave the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dogubayazit Dr Yasar Eryılmaz State Hospital
Ağrı, 01030
Gürkan İden, 05393825775, drgurkan_89@hotmail.com
About this study
Official title: The Effect of Pressure Ulcer Care Package on the Risk of Surgery-Related Pressure Ulcer Development in Patients Undergoing Orthopaedic Surgery
This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program.
- Conditions
- Pressure Ulcer
- Being tested
- Pressure ulcer prevention pack
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure ulcer prevention packOther
The pressure ulcer prevention package to be prepared by the researchers will be applied
| Study group | Role | What they receive |
|---|---|---|
| Care group | Experimental | The pressure ulcer care package to be prepared by the researchers will be implemented Receives: Other: Pressure ulcer prevention pack |
| Standard group | No intervention | Standard maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pressure ulcer formation
The 'Pressure Ulcer Sites and Stages Follow-up Form' created by the researchers will be used. With this form, pressure ulcer stages and regions of the patients will be monitored.In this Form, pressure wound stages are classified into stages: Stage I, II, III, IV, Unstageable, Deep Tissue, and Mucosal Membrane Pressure Wound.
Measured: Three days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start10 Apr 2024
- Primary completion10 Aug 2024
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Deniz Dogan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330506
- Sponsor's protocol ID
- 123456123456
- Status last verified
- Aug 2024
- First submitted
- 19 Mar 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pressure Ulcer Care Package on the Risk of Surgery-Related Pressure Ulcer Development in Patients Undergoing Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT06330506
- Acronym / sponsor ID
- 123456123456
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 26 Mar 2024 (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.
This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care group | Experimental | Other: Pressure ulcer prevention packThe pressure ulcer care package to be prepared by the researchers will be implemented |
| Standard group | No intervention | –Standard maintenance will be applied |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Orthopaedics and traumatology department
- Those who have undergone general or spinal anesthesia
- Without any communication problems
- Patients who volunteered to participate in the study
Key exclusion criteria (4 listed)
- Patients with pre-operative pressure ulcer
- Those who are bedridden
- Patients referred to the intensive care unit after surgery
- Patients who wish to leave the study will be 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 |
|---|---|---|
| Pressure ulcer prevention packThe pressure ulcer prevention package to be prepared by the researchers will be applied | Other | Care group |
Primary outcome
Evaluation of pressure ulcer formation
Time frame: Three days later
The 'Pressure Ulcer Sites and Stages Follow-up Form' created by the researchers will be used. With this form, pressure ulcer stages and regions of the patients will be monitored.In this Form, pressure wound stages are classified into stages: Stage I, II, III, IV, Unstageable, Deep Tissue, and Mucosal Membrane Pressure Wound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure ulcer prevention pack in people with Pressure Ulcer, run by Cukurova University 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 4 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sevban Arslan (+903223386484, sarslan@cu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pressure ulcer formation (time frame: Three days later). 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 23 Aug 2024.