NCT02844166

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

July 18, 2016

Last Update Submit

June 5, 2018

Conditions

Pressure UlcerSkin Ulcer

Outcome Measures

Primary Outcomes (1)

  • class II pressure injury

    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.

    through study completion, an average of 30 days

Secondary Outcomes (4)

  • Time to develop pressure injury

    through study completion, an average of 30 days

  • Length of ICU stay

    through study completion, an average of 30 days

  • Length of hospital stay

    through study completion, an average of 30 days

  • Mortality rate

    28 days

Study Arms (2)

viscoelastic group

EXPERIMENTAL

viscoelastic surface support

Other: viscoelastic surface support

pyramidal foam group

ACTIVE COMPARATOR

pyramidal foam surface support

Other: pyramidal foam surface support

Interventions

viscoelastic surface supportOTHER

Patients will be placed in an ICU bed with viscoelastic surface support

viscoelastic group
pyramidal foam surface supportOTHER

Patients will be placed in an ICU bed with pyramidal foam surface support

pyramidal foam group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted to ICU with Braden scale ≤ 14

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTI 2 Hospital Evangélico de Londrina

Londrina, Paraná, 86015-900, Brazil

Location

Related Publications (8)

  • Lardenoye JW, Thiefaine JA, Breslau PJ. Assessment of incidence, cause, and consequences of pressure ulcers to evaluate quality of provided care. Dermatol Surg. 2009 Nov;35(11):1797-803. doi: 10.1111/j.1524-4725.2009.01293.x. Epub 2009 Sep 2.

    PMID: 19732102BACKGROUND

  • Nixon J, McElvenny D, Mason S, Brown J, Bond S. A sequential randomised controlled trial comparing a dry visco-elastic polymer pad and standard operating table mattress in the prevention of post-operative pressure sores. Int J Nurs Stud. 1998 Aug;35(4):193-203. doi: 10.1016/s0020-7489(98)00023-6.

    PMID: 9801935BACKGROUND

  • Sprigle S, Sonenblum S. Assessing evidence supporting redistribution of pressure for pressure ulcer prevention: a review. J Rehabil Res Dev. 2011;48(3):203-13. doi: 10.1682/jrrd.2010.05.0102.

    PMID: 21480095BACKGROUND

  • Fulbrook P, Anderson A. Pressure injury risk assessment in intensive care: comparison of inter-rater reliability of the COMHON (Conscious level, Mobility, Haemodynamics, Oxygenation, Nutrition) Index with three scales. J Adv Nurs. 2016 Mar;72(3):680-92. doi: 10.1111/jan.12825. Epub 2015 Oct 14.

    PMID: 26462998BACKGROUND

  • Borghardt AT, Prado TN, Bicudo SD, Castro DS, Bringuente ME. Pressure ulcers in critically ill patients: incidence and associated factors. Rev Bras Enferm. 2016 Jun;69(3):460-7. doi: 10.1590/0034-7167.2016690307i. English, Portuguese.

    PMID: 27355294BACKGROUND

  • Rao AD, Preston AM, Strauss R, Stamm R, Zalman DC. Risk Factors Associated With Pressure Ulcer Formation in Critically Ill Cardiac Surgery Patients: A Systematic Review. J Wound Ostomy Continence Nurs. 2016 May-Jun;43(3):242-7. doi: 10.1097/WON.0000000000000224.

    PMID: 26983066BACKGROUND

  • Smit I, Harrison L, Letzkus L, Quatrara B. What Factors Are Associated With the Development of Pressure Ulcers in a Medical Intensive Care Unit? Dimens Crit Care Nurs. 2016 Jan-Feb;35(1):37-41. doi: 10.1097/DCC.0000000000000153.

    PMID: 26627071BACKGROUND

  • Santamaria N, Gerdtz M, Liu W, Rakis S, Sage S, Ng AW, Tudor H, McCann J, Vassiliou T, Morrow F, Smith K, Knott J, Liew D. Clinical effectiveness of a silicone foam dressing for the prevention of heel pressure ulcers in critically ill patients: Border II Trial. J Wound Care. 2015 Aug;24(8):340-5. doi: 10.12968/jowc.2015.24.8.340.

    PMID: 26562376BACKGROUND

MeSH Terms

Conditions

Pressure UlcerSkin Ulcer

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Cintia MC Grion

    UEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor adjunto

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 26, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

June 7, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)