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

Pressure Ulcer Clinical Trial

— PENFUP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02565745
• Other study ID #: 2222-2015
• Secondary ID: 277865740699
• Status: Terminated
• Phase: Phase 3
• First received: September 29, 2015
• Last updated: March 16, 2018
• Start date: December 2015
• Est. completion date: December 12, 2017

Study information

• Verified date: June 2017
• Source: Fundación Cardioinfantil Instituto de Cardiología
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 in-hospital PU

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 689
• Est. completion date: December 12, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

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:
• Moisturizing cream
It will be applied twice a day to the same skin areas as the experimental group

Locations

Country	Name	City	State
Colombia	Fundación Cardioinfantil Instituto de Cardiología	Bogotá	Cundinamarca
Colombia	Clinica Carlos Ardila Lulle-FOSCAL	Bucaramanga	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Cardioinfantil Instituto de Cardiología

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

Bergstrom N, Allman RM, Alvarez OM, Bennett MA, Carlson CE, Frantz RA, Garber SL, Jackson BS, Kaminski Jr MV, Kemp MG, Krouskop TA, Lewis Jr VL, Maklebust J, Margolis DJ, Marvel EM, Reger SI, Rodeheaver GT, Salcido R, Xakellis GC, Yarkony GM. Treatment of

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.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure ulcers	First skin ulcer identified in the covered body areas	During hospitalization
Secondary	Length of stay	Total stay in hours	During hospitalization
Secondary	Time to the first walk	First walk out of bed as registered in patients' charts	During hospitalization
Secondary	Total cost of hospitalization	Total bill to insurer	During hospitalization