Comparison of the Pressure Ulcer Prevention Effects of Two Mattresses With Different Support Surfaces Used in Bedridden Patients

Pressure Ulcer Clinical Trial

Official title:

Comparison of the Pressure Ulcer Prevention Effects of Two Mattresses With Different Support Surfaces Used in Bedridden Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06116123
• Other study ID #: ataturk university
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Nursing Caries
• Pressure Ulcer
• Ulcer

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.