deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT02565745

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

Conditions Pressure Ulcer
Updated 8 times since 2017 Last updated: Mar 16, 2018 Started: Dec 31, 2015 Primary completion: Aug 31, 2017 Completion: Dec 12, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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A PHASE3 clinical study on Pressure Ulcer, this trial is terminated or withdrawn.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

~Jan 2017 – ~Jul 2017 · 6 months · monthly snapshotNot Yet Recruiting~Jul 2017 – ~Apr 2018 · 9 months · monthly snapshotRecruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Present [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE3

Show 3 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Terminated PHASE3

    Status: RecruitingTerminated

  2. Jul 2017 — Apr 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting · Phase: NAPHASE3

  3. 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

Sponsor contact:
  • Fundación Cardioinfantil Instituto de Cardiología
Data source: Fundación Cardioinfantil Instituto de Cardiología

For direct contact, visit the study record on ClinicalTrials.gov .