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

Phase 3

Terminated

• Conditions: Pressure Ulcer
• Interventions: Combination Product: Skin dressing; Other: Moisturizing cream

• Registration Number: NCT02565745
• Lead Sponsor: Fundación Cardioinfantil Instituto de Cardiología

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

Study Timeline

• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Study Start: 2015-12
• Status Verified: 2017-06
• Primary Completion: 2017-08-31
• Study Completion: 2017-12-12
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 689

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin Dressing	Skin dressing	Hydrocolloid dressings applied during hospitalization
Moisturizing cream	Moisturizing cream	Use of moisturizing cream, as part of conventional skin care

Primary Outcome Measures

Name	Time	Method
Pressure ulcers	During hospitalization	First skin ulcer identified in the covered body areas

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Clinica Carlos Ardila Lulle-FOSCAL; 🇨🇴 Bucaramanga, Santander, Colombia

Fundación Cardioinfantil Instituto de Cardiología; 🇨🇴 Bogotá, Cundinamarca, Colombia