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
Sponsor: Fundación Cardioinfantil Instituto de Cardiología
Terminated
Recommendation after interim analysis
A PHASE3 clinical study on Pressure Ulcer, this trial is terminated or withdrawn. The trial is conducted by Fundación Cardioinfantil Instituto de Cardiología and has accumulated 8 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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
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
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE3
-
Sep 2024 — Present [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE3
▶ Show 3 earlier versions
-
Apr 2018 — Jun 2018 [monthly]
Terminated PHASE3
Status: Recruiting → Terminated
-
Jul 2017 — Apr 2018 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting · Phase: NA → PHASE3
-
Jan 2017 — Jul 2017 [monthly]
Not Yet Recruiting NA
First recorded
Dec 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Fundación Cardioinfantil Instituto de Cardiología
For direct contact, visit the study record on ClinicalTrials.gov .