Clinical trial NCT02565745: Skin Dressings Versus Lubrication to Prevent Pressure Ulcers: A Randomized Trial
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pressure Ulcer
Keywords: Prevention
Pressure ulcers
Clinical trial
Nursing
Lead sponsor: Fundación Cardioinfantil Instituto de Cardiología
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 689
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Pressure ulcers
timeFrame: During hospitalization
Secondary outcomes:
measure: Length of stay
timeFrame: During hospitalization
measure: Time to the first walk
timeFrame: During hospitalization
measure: Total cost of hospitalization
timeFrame: During hospitalization
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Cardioinfantil Instituto de Cardiología
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Clinica Carlos Ardila Lulle-FOSCAL
state: Santander
Study officials:
affiliation: Fundacion Cardioinfantil Instituto de Cardiología
name: Olga L Cortés, RN,MSC,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: McInnes E, Jammali-Blasi A, Bell-Syer SE, Dumville JC, Cullum N. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2011 Apr 13;(4):CD001735. doi: 10.1002/14651858.CD001735.pub4.