Skin Dressings Versus Lubrication to Prevent Pressure Ulcers: A Randomized Trial
NCT ID: NCT02565745
Last Updated: 2018-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
689 participants
INTERVENTIONAL
2015-12-31
2017-12-12
Brief Summary
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To assess if - in adult patients admitted to hospital with surgical or medical conditions at high/very high risk of developing pressure ulcers (PU) according to Braden scale - using skin dressing protection versus conventional care (lubricant or moisturizer cream) may prevent the incidence of in-hospital PU
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Detailed Description
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Trained nurses will review all participants' charts and verify any report of PU until the first ambulation, discharge or death. Patients with a verified PU are referred to the institutional wound care group.
For the purpose of outcome adjudication, study personnel will email digital pictures to 2 independent, blinded outcome assessors (experts in skin care). Skin lesions will be rated in 4-level scale (EPUAP/NPUAP). In case of disagreement, a single, independent referee will confirm the presence/absence of any potential PU.
The unit for analysis will be patients developing (first occurrence, in a time-to-event analysis) PUs in the areas covered by the interventions.
See further details on eligibility, interventions and study outcomes below
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Skin Dressing
Hydrocolloid dressings applied during hospitalization
Skin dressing
Pre-determined skin areas at risk for PUs (3 or more, depending on the prevaliing body position, prone, supine or Sims') will be covered. Dressings will be changed every 6-7 days unless found wet/contaminated
Moisturizing cream
Use of moisturizing cream, as part of conventional skin care
Moisturizing cream
It will be applied twice a day to the same skin areas as the experimental group
Interventions
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Skin dressing
Pre-determined skin areas at risk for PUs (3 or more, depending on the prevaliing body position, prone, supine or Sims') will be covered. Dressings will be changed every 6-7 days unless found wet/contaminated
Moisturizing cream
It will be applied twice a day to the same skin areas as the experimental group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* High/very high risk of PU (Braden´s scale ≤ 20 points) will be eligible.
Exclusion Criteria
* Need for chronic use of diapers
18 Years
90 Years
ALL
No
Sponsors
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Fundación Cardioinfantil Instituto de Cardiología
OTHER
Responsible Party
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Principal Investigators
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Olga L Cortés, RN,MSC,PhD
Role: PRINCIPAL_INVESTIGATOR
Fundacion Cardioinfantil Instituto de Cardiología
Locations
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Fundación Cardioinfantil Instituto de Cardiología
Bogotá, Cundinamarca, Colombia
Clinica Carlos Ardila Lulle-FOSCAL
Bucaramanga, Santander Department, Colombia
Countries
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References
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Bergstrom N, Braden B, Kemp M, Champagne M, Ruby E. Predicting pressure ulcer risk: a multisite study of the predictive validity of the Braden Scale. Nurs Res. 1998 Sep-Oct;47(5):261-9. doi: 10.1097/00006199-199809000-00005.
Moore ZE, Webster J. Dressings and topical agents for preventing pressure ulcers. Cochrane Database Syst Rev. 2013 Aug 18;(8):CD009362. doi: 10.1002/14651858.CD009362.pub2.
McInnes E, Jammali-Blasi A, Bell-Syer SE, Dumville JC, Cullum N. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2011 Apr 13;(4):CD001735. doi: 10.1002/14651858.CD001735.pub4.
Cortes OL, Herrera VM, Salazar LD, Rojas YA, Esparza M, Taborda A, Dennis RJ. Impact of hydrocolloid dressings in the prevention of pressure ulcers in high-risk patients: a randomized controlled trial (PENFUP). Sci Rep. 2023 Dec 7;13(1):21639. doi: 10.1038/s41598-023-47483-0.
Other Identifiers
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277865740699
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2222-2015
Identifier Type: -
Identifier Source: org_study_id
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