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

Fundación Cardioinfantil Instituto de Cardiología

Status and phase: Terminated; Phase 3

Conditions: Pressure Ulcer

Treatments: Combination Product: Skin dressing; Other: Moisturizing cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02565745

277865740699 (Other Grant/Funding Number)

2222-2015

Details and patient eligibility

About

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

Full 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

Enrollment: 689 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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689 participants in 2 patient groups

Skin Dressing

Experimental group

Description:

Hydrocolloid dressings applied during hospitalization

Treatment:

Combination Product: Skin dressing

Moisturizing cream

Active Comparator group

Description:

Use of moisturizing cream, as part of conventional skin care

Treatment:

Other: Moisturizing cream