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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02565745

Acronym

PENFUP

Enrollment

689

Registered

2015-10-01

Start date

2015-12-31

Completion date

2017-12-12

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

Keywords

Prevention, Pressure ulcers, Clinical trial, Nursing

Brief 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

Interventions

COMBINATION_PRODUCTSkin 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

OTHERMoisturizing cream

It will be applied twice a day to the same skin areas as the experimental group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Pressure ulcers	During hospitalization	First skin ulcer identified in the covered body areas

Secondary

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

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026