Skin Dressings Versus Lubrication to Prevent Pressure Ulcers: A Randomized

Status Terminated

Clinical Trial Summary

Study purpose:

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

Clinical Trial Description

Participants will receive, in addition to the experimental/control interventions, background skin care measures, including anti- bedsore mattresses; body position changes every two hours, and shear/friction reduction.

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02565745
Study type	Interventional
Source	Fundación Cardioinfantil Instituto de Cardiología
Contact
Status	Terminated
Phase	Phase 3
Start date	December 2015
Completion date	December 12, 2017

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Skin Dressings Versus Lubrication to Prevent Pressure Ulcers: A Randomized Trial — PENFUP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms