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
| Registry | NCT02565745, acronym PENFUP |
|---|---|
| Status | Terminated - Recommendation after interim analysis |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 689 (Actual) |
| Sponsor | Fundación Cardioinfantil Instituto de Cardiología (Other) |
| Conditions | Pressure Ulcer |
| Interventions | Skin dressing, Moisturizing cream (Combination product, other) |
| Dates | start 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 in Colombia |
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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
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Skin Dressing | Experimental | Combination Product: Skin dressing | Hydrocolloid dressings applied during hospitalization |
| Moisturizing cream | Active comparator | Other: Moisturizing cream | Use of moisturizing cream, as part of conventional skin care |
Sex: All, ages: 18 Years to 90 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Fundación Cardioinfantil Instituto de Cardiología | Bogotá, Cundinamarca | Colombia | |
| Clinica Carlos Ardila Lulle-FOSCAL | Bucaramanga, Santander Department | Colombia |