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

Study Overview

• Status: Terminated
• Conditions: Pressure Ulcer
• Intervention / Treatment: Combination product: Skin dressing; Other: Moisturizing cream

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

• Study Type: Interventional
• Enrollment (Actual): 689
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia
      • Fundación Cardioinfantil Instituto de Cardiología
  • Santander
    • Bucaramanga, Santander, Colombia
      • Clinica Carlos Ardila Lulle-FOSCAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skin Dressing; Hydrocolloid dressings applied during hospitalization	Combination product: Skin 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; Other Names: Hydrocolloid dressing
Active Comparator: Moisturizing cream; Use of moisturizing cream, as part of conventional skin care	Other: Moisturizing cream; It will be applied twice a day to the same skin areas as the experimental group; Other Names: Skin lubricant

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundación Cardioinfantil Instituto de Cardiología
• Investigators: Principal Investigator: Olga L Cortés, RN,MSC,PhD, Fundación Cardioinfantil Instituto de Cardiología

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): December 12, 2017

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Prevention; Nursing; Clinical trial; Pressure ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: 2222-2015; 277865740699 (Other Grant/Funding Number: Colciencias)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No