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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Combination Product: Skin dressing
* Other: Moisturizing cream


Participation Criteria
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Eligibility Criteria
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Inpatients will be eligible if meeting two criteria: Intact skin on hospital admission High/very high risk of PU (Braden´s scale ≤ 20 points) will be eligible. Exclusion Criteria: Treating physician disagree with participation Need for chronic use of diapers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin Dressing<br>Hydrocolloid dressings applied during hospitalization | Combination Product: Skin dressing<br>* 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<br>* Other names: Hydrocolloid dressing;|
| Active Comparator: Moisturizing cream<br>Use of moisturizing cream, as part of conventional skin care | Other: Moisturizing cream<br>* It will be applied twice a day to the same skin areas as the experimental group<br>* Other names: Skin lubricant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure ulcers | First skin ulcer identified in the covered body areas | During hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Total stay in hours | During hospitalization | 
| Time to the first walk | First walk out of bed as registered in patients' charts | During hospitalization | 
| Total cost of hospitalization | Total bill to insurer | During hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Pressure ulcers, Clinical trial, Nursing