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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
Sponsor:
Collaborator:
Delta Light Ind e Com de Equipamentos Eletrônicos Ltda
Information provided by (Responsible Party):
Cintia Magalhães Carvalho Grion, Universidade Estadual de Londrina

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Length of ICU stay [ Time Frame: through study completion, an average of 30 days ]
    Time from intensive care unit admission until discharge from ICU.

  3. Length of hospital stay [ Time Frame: through study completion, an average of 30 days ]
    Time from intensive care unit admission until hospital discharge.

  4. Mortality rate [ Time Frame: 28 days ]
    Vital status considered non survival at 28 days after intensive care unit admission.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients admitted to ICU with Braden scale ≤ 14

Exclusion Criteria:

  • age under 18 years
  • less than 24 hours of ICU length of stay
  • contraindication for performing complete institutional preventive measures for support injuries
  • presence of support injuries at ICU admission
  • absence of informed consent

Information from the National Library of Medicine

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


Locations
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Brazil
UTI 2 Hospital Evangélico de Londrina
Londrina, Parana, Brazil, 86015-900
Sponsors and Collaborators
Universidade Estadual de Londrina
Delta Light Ind e Com de Equipamentos Eletrônicos Ltda
Investigators
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Principal Investigator: Cintia MC Grion UEL
Publications:

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Responsible Party: Cintia Magalhães Carvalho Grion, Professor adjunto, Universidade Estadual de Londrina
ClinicalTrials.gov Identifier: NCT02844166    
Other Study ID Numbers: GETI-001
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pressure Ulcer
Skin Ulcer
Ulcer
Crush Injuries
Pathologic Processes
Skin Diseases
Wounds and Injuries