- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06116123
Comparison of the Pressure Ulcer Prevention Effects of Two Mattresses With Different Support Surfaces Used in Bedridden Patients
Aim: This study was conducted to investigate the effectiveness of two types of mattresses with different support surfaces used in bedridden patients.
Method: The sample of this quasi-experimental study consisted of 60 patients according to the inclusion criteria. A group I and group II of 30 patients each were formed from the sampled patients. For the patients in group I, a bed with a cube/block system and vibration (massage) feature was used. For the patients in group II, a viscoelastic mattress was used. The data of the study were collected with the ''Patient Identification Form'', ''Braden Scale'', ''Pressure Wound Observation Form'' and ''Wound Measurement Chart''. Number-percentage distributions, Chi-square, Fisher's Exact Probability Test and Mann-Whitney-U tests were used to evaluate the data.
Implications for Clinical Practice: It was determined that the support surface used affected the pressure sore size and the mattress with cube/block system and vibration (massage) feature created smaller sized wounds in the sacrum, trochanter, malleolus and heel regions. In the sacrum, scapula, and heel regions, although not statistically significant in terms of wound stage and the number of patients who developed pressure sores, it was seen that the mattress with cube/block system and vibration (massage) feature was more effective.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Agri, Turkey, 042000
- Agri Ibrahim Cecen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A "low risk" rating on the Braden Scale.
- Voluntary informed consent from conscious patients and consent from the legal guardian for unconscious or confused patients.
- Absence of pressure sores upon admission to the clinics.
- A BMI (Body Mass Index) not exceeding 30.00 (as classified by the World Health Organization).
Exclusion Criteria:
- The patient's bed was changed in less than ten days after inclusion in the study,
- Patient referral,
- Discharge
- Exhitus was the exclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group I (Massage mattress with cube/block system)
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Patients with an odd number were assigned to group I, while those with an even number were allocated to group II.
Patients in group I were provided with a pressure sore prevention bed featuring a support surface with vibration (massage) capabilities, a cube/block system creating a low-pressure area, and a ventilation system, routinely utilized in the unit.
For group II patients, a viscoelastic pressure sore prevention mattress with an orthopedic support surface, routinely employed in the unit, was used.Within the first six hours after admission, patients in both groups underwent initial assessments using the Braden Scale to determine their pressure sore risk.
Both groups were monitored for a maximum of four weeks, with daily pressure ulcer assessments conducted using the Pressure Ulcer Observation Form.
Pressure sore area in both groups was calculated in square centimeters (cm2) using the Wound Measurement Ruler.
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No Intervention: Group II (Standard of care)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of patients without pressure ulcers
Time Frame: Patients were followed up for four weeks.
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The formation of pressure sores in patients will be prevented with a bed with cube/block system massage feature.
The massage feature of the bed will be used for this.
In addition, the pressure in the relevant area will be reduced by removing the cubes inside the bed.
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Patients were followed up for four weeks.
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Collaborators and Investigators
Sponsor
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
- Atatürk University (Other Identifier: Scientific Research Projects Coordination Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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