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Trial registered on ANZCTR


Registration number
ACTRN12617000439347
Ethics application status
Approved
Date submitted
23/03/2017
Date registered
27/03/2017
Date last updated
11/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Estimating prevalence of impaired skin surrounding devices: the EPISODE study
Scientific title
A prospective, observational study to estimate the prevalence of impaired skin surrounding Central Venous Access Devices within an adult cancer care services setting.
Secondary ID [1] 291525 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EPISODE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Venous Access Device (CVAD) associated skin injury 302612 0
Cancer 302618 0
Condition category
Condition code
Public Health 302136 302136 0 0
Health service research
Cancer 302141 302141 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Any patient with a Central Venous Access Device (CVAD) admitted to cancer care services unit will be eligible to participate in this prevalence audit. Patients will have demographic data collected: e.g. admitting diagnosis, co-morbidities and CVAD characteristics.

Participants will be reviewed by a research nurse once weekly (standard) or twice weekly (if there are any signs of skin impairment). All changes to the skin surrounding the CVAD site will be documented. These changes will be categorised into known skin damage diagnoses using visual prompts and definitions, including pressure injuries (Graded 1,2,3,4 ) skin stripping, tension injury or blister, erythema, skin tear, irritant contact dermatitis, allergic dermatitis and maceration. Participants will be monitored until discharge from hospital.
Intervention code [1] 297595 0
Not applicable
Comparator / control treatment
Not applicable - observational study only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301567 0
Prevalence of Central Venous Access Devices (CVAD) associated skin injury,
This will be assessed using visual prompts and definitions on a data collection system, including pressure injuries (Graded 1,2,3,4 ), skin stripping, tension injury or blister, erythema, skin tear, irritant contact dermatitis, allergic dermatitis and maceration.
Timepoint [1] 301567 0
Assessed by a research nurse once weekly (standard) or twice weekly (if there are any signs of skin impairment) until the time of patient discharge or death.
Secondary outcome [1] 333049 0
Management/escalation of CVAD management following CVAD associated skin injury
Timepoint [1] 333049 0
Assessed by a research nurse once weekly (standard) or twice weekly (if there are any signs of skin impairment) until the time of patient discharge or death.

Eligibility
Key inclusion criteria
1. Patient receiving care within a Cancer Care Services inpatient unit.
2. CVAD in place (includes peripherally inserted central catheter (PICC), haemodialysis catheter, non-tunnelled percutaneously CVAD, tunnelled CVAD, pulmonary artery catheter, umbilical catheter, totally implantable CVAD)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1, Other types of vascular access device (peripheral vascular catheter, arterial catheter).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Continuous variables will be described as mean, range and standard deviation values. Categorical data will be described using frequencies and percentages. Associations between CVAD-associated skin impairment and clinical characteristics will be assessed using Chi-square, Mann-Whitney U and Kruskall-Wallis tests, as appropriate. Variables with a p<0.05 will be considered significant. Data will be analysed using PASW 22.0 (SPSS Inc, Chicago, IL).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/03/2017
Actual
28/03/2017
Date of last participant enrolment
Anticipated
23/03/2018
Actual
21/03/2018
Date of last data collection
Anticipated
30/03/2018
Actual
27/03/2018
Sample size
Target
500
Accrual to date
Final
627
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7726 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 15649 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 296013 0
Charities/Societies/Foundations
Name [1] 296013 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 296013 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Rd
Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 294901 0
Hospital
Name [1] 294901 0
Royal Brisbane and Women's Hospital
Address [1] 294901 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Rd
Herston, QLD 4029
Country [1] 294901 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297274 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 297274 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street
South Brisbane, QLD, 4101
Ethics committee country [1] 297274 0
Australia
Date submitted for ethics approval [1] 297274 0
18/08/2016
Approval date [1] 297274 0
15/09/2016
Ethics approval number [1] 297274 0
HREC/16/QRCH/310
Ethics committee name [2] 297276 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 297276 0
Office for Research (Bray Centre)
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Ethics committee country [2] 297276 0
Australia
Date submitted for ethics approval [2] 297276 0
Approval date [2] 297276 0
27/10/2016
Ethics approval number [2] 297276 0
2016/835

Summary
Brief summary
This observational study will explore the prevalence and risk factors of central venous access device (CVAD) associated skin injury and the types of skin injuries which occur in cancer patients.

Who is it for?
You may be eligible to join this study if you are aged 16 years or above, are receiving care within a Cancer Care Services inpatient unit, and have a CVAD in place.

Study details
All participants in this study will have the skin surrounding their CVAD device assessed by a study nurse once per week, or twice per week if there are any signs of skin injury, for the duration of their hospital admission. Nurses will also note any management/treatment received for the CVAD-associated skin injury if present.

It is hoped that the results of this study will help researchers to understand the prevalence of CVAD-associated skin injuries, in order to support the development of evidence-based solutions for their prevention and treatment in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73546 0
Ms Amanda Ullman
Address 73546 0
School of Nursing and Midwifery
Nathan campus, Griffith University
170 Kessels Road
Nathan, QLD 4111
Country 73546 0
Australia
Phone 73546 0
+617 3735 6462
Fax 73546 0
Email 73546 0
a.ullman@griffith.edu.au
Contact person for public queries
Name 73547 0
Amanda Ullman
Address 73547 0
School of Nursing and Midwifery
Nathan campus, Griffith University
170 Kessels Road
Nathan, QLD 4111
Country 73547 0
Australia
Phone 73547 0
+617 3735 6462
Fax 73547 0
Email 73547 0
a.ullman@griffith.edu.au
Contact person for scientific queries
Name 73548 0
Amanda Ullman
Address 73548 0
School of Nursing and Midwifery
Nathan campus, Griffith University
170 Kessels Road
Nathan, QLD 4111
Country 73548 0
Australia
Phone 73548 0
+617 3735 6462
Fax 73548 0
Email 73548 0
a.ullman@griffith.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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