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Pressure UlcerPhase 3PENFUPNCT02565745

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

A Phase 3 study testing Skin dressing and Moisturizing cream in people with Pressure Ulcer, run by Fundación Cardioinfantil Instituto de Cardiología at 2 sites in Colombia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Pressure Ulcer
What is being tested?
Skin dressing and Moisturizing cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
689 participants
Where
2 sitesColombia
Study dates
Dec 2015to 12 Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Treating physician disagree with participation
  • Need for chronic use of diapers

Trial locations and contacts

2 sites in 1 country.

Colombia2 sites

  • Fundación Cardioinfantil Instituto de Cardiología

    Bogotá, Cundinamarca

  • Clinica Carlos Ardila Lulle-FOSCAL

    Bucaramanga, Santander Department

Other trials in Colombia

About this study

Official title: 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

Read the 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

Conditions
Pressure Ulcer
Being tested
Skin dressing, Moisturizing cream
Keywords
Prevention, Pressure ulcers, Clinical trial, Nursing
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skin dressingCombination product

    Also called Hydrocolloid 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

  • Moisturizing creamOther

    Also called Skin lubricant

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

Study groups in NCT02565745
Study groupRoleWhat they receive
Skin DressingExperimentalHydrocolloid dressings applied during hospitalization
Receives: Combination Product: Skin dressing
Moisturizing creamActive comparatorUse of moisturizing cream, as part of conventional skin care
Receives: Other: Moisturizing cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure ulcers

    First skin ulcer identified in the covered body areas

    Measured: During hospitalization

Secondary outcomes (3)

  1. Length of stay

    Total stay in hours

    Measured: During hospitalization

  2. Time to the first walk

    First walk out of bed as registered in patients' charts

    Measured: During hospitalization

  3. Total cost of hospitalization

    Total bill to insurer

    Measured: During hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2015 (estimated)
  2. Study startDec 2015
  3. Primary completion31 Aug 2017
  4. Study completion12 Dec 2017

Why it stopped: Recommendation after interim analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
689 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02565745
Sponsor's protocol ID
2222-2015
Other IDs
277865740699
Acronym
PENFUP
Status last verified
Jun 2017
First submitted
29 Sep 2015
Last updated
20 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9766454

  • 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.

    PubMed 23955535

  • 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.

  • Cortes OL, Herrera VM, Salazar LD, Rojas YA, Esparza M, Taborda A, Dennis RJ. Impact of hydrocolloid dressings in the prevention of pressure ulcers in high-risk patients: a randomized controlled trial (PENFUP). Sci Rep. 2023 Dec 7;13(1):21639. doi: 10.1038/s41598-023-47483-0.

    PubMed 38062132

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Skin dressing and Moisturizing cream in people with Pressure Ulcer, run by Fundación Cardioinfantil Instituto de Cardiología at 2 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recommendation after interim analysis). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure ulcers (time frame: During hospitalization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02565745, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.

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