Pressure UlcerNCT06116123
Comparison of the Pressure Ulcer Prevention Effects of Two Mattresses With Different Support Surfaces Used in Bedridden Patients
A study testing Massage mattress with cube/block system in people with Pressure Ulcer and Nursing Caries, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Nursing Caries
- What is being tested?
- Massage mattress with cube/block system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2021to 20 Dec 2021
- 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
- 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).
Who cannot join
- The patient's bed was changed in less than ten days after inclusion in the study,
- Patient referral,
- Discharge
- Exhitus was the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pressure Ulcer, Nursing Caries
- Being tested
- Massage mattress with cube/block system
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage mattress with cube/block systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Massage mattress with cube/block system) | Experimental | Not described Receives: Device: Massage mattress with cube/block system |
| Group II (Standard of care) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without pressure ulcers
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.
Measured: Patients were followed up for four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start2 Mar 2021
- Primary completion12 Sep 2021
- Study completion20 Dec 2021
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan DENİZ, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116123
- Sponsor's protocol ID
- ataturk university
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pressure Ulcer Prevention Effects of Two Mattresses With Different Support Surfaces Used in Bedridden Patients
- ClinicalTrials.gov ID
- NCT06116123
- Acronym / sponsor ID
- ataturk university
- Conditions
- Pressure Ulcer, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 12 Sep 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 3 Nov 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Massage mattress with cube/block system) | Experimental | Device: Massage mattress with cube/block system |
| Group II (Standard of care) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- The patient's bed was changed in less than ten days after inclusion in the study,
- Patient referral,
- Discharge
- Exhitus was the exclusion criteria.
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 |
|---|---|---|
| Massage mattress with cube/block systemPatients 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. | Device | Group I (Massage mattress with cube/block system) |
Primary outcome
Number of patients without pressure ulcers
Time frame: Patients were followed up for four weeks.
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.
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 3 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage mattress with cube/block system in people with Pressure Ulcer and Nursing Caries, run by Agri Ibrahim Cecen 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: finished, as of the sponsor's last update on 3 Nov 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?
Number of patients without pressure ulcers (time frame: Patients were followed up for four weeks.). 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 3 Nov 2023.