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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06116123
Other study ID # ataturk university
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2021
Est. completion date December 20, 2021

Study information

Verified date October 2023
Source Agri Ibrahim Cecen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 20, 2021
Est. primary completion date September 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Massage mattress with cube/block system
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.

Locations

Country Name City State
Turkey Agri Ibrahim Cecen University Agri

Sponsors (1)

Lead Sponsor Collaborator
Agri Ibrahim Cecen University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Patients were followed up for four weeks.
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