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

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

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

Outcome assessors unaware of the treatment allocation will be sent photographs of the target skin areas with suspected PUs.

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

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

Bergstrom N, Braden B, Kemp M, Champagne M, Ruby E. Predicting pressure ulcer risk: a multisite study of the predictive validity of the Braden Scale. Nurs Res. 1998 Sep-Oct;47(5):261-9. doi: 10.1097/00006199-199809000-00005.

Moore ZE, Webster J. Dressings and topical agents for preventing pressure ulcers. Cochrane Database Syst Rev. 2013 Aug 18;(8):CD009362. doi: 10.1002/14651858.CD009362.pub2.

McInnes E., Jammali-Blasi A., Bell-Syer S., Dumville JC., Cullum N. Support surfaces for pressure ulcer prevention (Review). The Cochrane Library. Published Online: 13 Apr 2011.http://www.thecochranelibrary.com.wiley.com/doi/10.1002.