NCT02565745

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
689

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
Last Updated

March 20, 2018

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

September 29, 2015

Last Update Submit

March 16, 2018

Conditions

Pressure Ulcer

Keywords

PreventionPressure ulcersClinical trialNursing

Outcome Measures

Primary Outcomes (1)

  • Pressure ulcers

    First skin ulcer identified in the covered body areas

    During hospitalization

Secondary Outcomes (3)

  • Length of stay

    During hospitalization

  • Time to the first walk

    During hospitalization

  • Total cost of hospitalization

    During hospitalization

Study Arms (2)

Skin Dressing

EXPERIMENTAL

Hydrocolloid dressings applied during hospitalization

Combination Product: Skin dressing

Moisturizing cream

ACTIVE COMPARATOR

Use of moisturizing cream, as part of conventional skin care

Other: Moisturizing cream

Interventions

Skin dressingCOMBINATION_PRODUCT

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

Also known as: Hydrocolloid dressing
Skin Dressing
Moisturizing creamOTHER

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

Also known as: Skin lubricant
Moisturizing cream

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundación Cardioinfantil Instituto de Cardiología

Bogotá, Cundinamarca, Colombia

Location

Clinica Carlos Ardila Lulle-FOSCAL

Bucaramanga, Santander Department, Colombia

Location

Related Publications (4)

  • 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 pressure ulcers. Clinical Practice Guideline, No. 15. 1994. AHCPR Publication No. 95-0652. Rockville, MD: U.S. Bergstrom, N, Braden, B, Champagne, M, Kemp, M, & Ruby, E. Predicting pressure ulcer risk: a multisite study of the predictive validity of the Braden Scale. Nursing Research, 1998;47(5):261-269.

    RESULT

  • 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.

    PMID: 23955535RESULT

  • 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.

    PMID: 21491384RESULT

  • 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.

    PMID: 38062132DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Biological DressingsBandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Olga L Cortés, RN,MSC,PhD

    Fundacion Cardioinfantil Instituto de Cardiología

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcome assessors unaware of the treatment allocation will be sent photographs of the target skin areas with suspected PUs.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 1, 2015

Study Start

December 1, 2015

Primary Completion

August 31, 2017

Study Completion

December 12, 2017

Last Updated

March 20, 2018

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CO(2)