Support Surfaces to Prevent Pressure Injuries (SURFACE)
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|ClinicalTrials.gov Identifier: NCT02844166|
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : June 7, 2018
The presence of pressure injuries has been considered a quality indicator of health care services and efforts has been made to develop guidelines to prevent this issue. Intensive care unit admissions (ICU) are recognized as risk factors to develop pressure injuries due to reduced mobility of critically ill patients and large number of devices and hard technologies that jeopardize preventive measures, such as, decubitus changes. There are not current definitive evidence about the superiority of any support surface to treat or prevent pressure injuries. The objective of the present study is to analyze if the use of viscoelastic support surface in vulnerable critically ill patients decreases the incidence of pressure injury compared with pyramidal foam support surface.
Randomized clinical trial performed in an intensive care unit for adult patients in a philanthropic hospital. Inclusion criteria are patients admitted to ICU with Braden scale ≤ 14. Exclusion criteria are age under 18 years, less than 24 hours of ICU length of stay, contraindication of performing complete institutional preventive measures for support injuries, presence of support injuries at ICU admission or absence of informed consent. Randomization will be made by computerized generated numbers and patients will be allocated in two groups in a ratio of 1:1. All study patients will be cared for according to standard institutional preventive measures. The interventional group will be placed in an ICU bed with viscoelastic support surface and the control group in an ICU bed with pyramidal foam support surface. The main outcome evaluated will be the occurrence of type II pressure injury. Secondary outcomes are the time to the occurrence of pressure injury, length of ICU and hospital stay and 28 days mortality rate. Significance level will be 5%.
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer Skin Ulcer||Other: viscoelastic surface support Other: pyramidal foam surface support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Support Surfaces in the Incidence of Pressure Injuries in Critically Ill Patients: a Randomized Clinical Trial|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||April 2017|
Experimental: viscoelastic group
viscoelastic surface support
Other: viscoelastic surface support
Patients will be placed in an ICU bed with viscoelastic surface support
Active Comparator: pyramidal foam group
pyramidal foam surface support
Other: pyramidal foam surface support
Patients will be placed in an ICU bed with pyramidal foam surface support
- class II pressure injury [ Time Frame: through study completion, an average of 30 days ]Partial-thickness loss of skin with exposed dermis. The wound bed is viable, pink or red, moist, and may also present as an intact or ruptured serum-filled blister. Adipose (fat) is not visible and deeper tissues are not visible. Granulation tissue, slough and eschar are not present.
- Time to develop pressure injury [ Time Frame: through study completion, an average of 30 days ]Time from intensive care unit admission to identification of class II pressure injury
- Length of ICU stay [ Time Frame: through study completion, an average of 30 days ]Time from intensive care unit admission until discharge from ICU.
- Length of hospital stay [ Time Frame: through study completion, an average of 30 days ]Time from intensive care unit admission until hospital discharge.
- Mortality rate [ Time Frame: 28 days ]Vital status considered non survival at 28 days after intensive care unit admission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844166
|UTI 2 Hospital Evangélico de Londrina|
|Londrina, Parana, Brazil, 86015-900|
|Principal Investigator:||Cintia MC Grion||UEL|