NCT02565745

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

Impact of Skin Dressings Compared With Cream for Skin Lubrication in the Prevention of Pressure Ulcers in Patients at High or Very High Risk: A Multicenter Randomized Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 689 (actual)
• Sponsor: Fundación Cardioinfantil Instituto de Cardiología · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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
OTHER	Moisturizing cream	It will be applied twice a day to the same skin areas as the experimental group

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-08-31
• Completion: 2017-12-12
• First posted: 2015-10-01
• Last updated: 2018-03-20

Locations

2 sites across 1 country: Colombia