Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000294651
Ethics application status
Approved
Date submitted
24/01/2023
Date registered
17/03/2023
Date last updated
17/03/2023
Date data sharing statement initially provided
17/03/2023
Date results information initially provided
17/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Skin Tear healing outcomes utilising two differing wound dressing types.
Scientific title
Pilot Study: Adhesive silicone foam dressing versus meshed silicone interface dressing for the management of skin tears: a comparison of healing rates, patients’ and nurses’ satisfaction.
Secondary ID [1] 308538 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Tears 328461 0
Wound healing 328913 0
Condition category
Condition code
Skin 325493 325493 0 0
Other skin conditions
Injuries and Accidents 325905 325905 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study assessed Skin Tear healing trends with the use of two differing wound dressing products which were used as part of standard practice to ascertain which product provided the best outcomes. These two dressings were Mepilex Border (adhesive silicone foam dressing) and Mepitel (meshed silicone interface dressing).
Both products are manufactured by the same company and fall into the generic category of soft silicone dressings and utilise what is called ‘Safetac Soft Silicone Technology’ (SSST). While they share the same SSST, they are completely different in terms of appearance, application, and usage.
Mepilex Border is a self-adhesive waterproof dressing with foamlike like properties that absorb exudate and evaporate excess exudate (wound ooze) through the top of the dressing via moisture vapour permeability. The dressing contact layer (which sits on the skin) contains the SSST. When placed onto a skin tear this layer anchors the skin flap preventing movement. The absorptive pad absorbs the exudate preventing maceration of the flap and periwound area.
Mepitel is a wound contact layer not unlike traditional tulle gras (paraffin coated open weave gauze) in appearance; however unlike this traditional dressing, Mepitel is wholly constructed with the SSST. This dressing is placed on a skin tear and the surrounding skin, the SSST anchors the skin flap to the surrounding skin and allows exudate to pass through the dressing. This dressing requires a secondary covering to be placed on top to absorb the exudate, for example a combine pad (cotton wool) and then a bandage to hold the dressing in place.
Patients were randomised into two treatment arms with their Skin Tears dressed either with the adhesive silicone foam dressing or the meshed silicone interface dressing. Apart from the two different products used, the total care procedure was the same for both. The Research Nurse/Assistant (RA) collected baseline data when the skin tear was first assessed, with follow-up data collected at 7 days, 14 days, and 21 days.
The RA was responsible for undertaking the dressing (which includes removal of the old dressing, wound cleansing and dressing reapplication - in accordance with the Hospital Wound Management Procedure) as per the random allocation at each data collection time. As per the manufactures guidelines and the protocol, both these dressings were to remain in place for the 7 days between the RA visits.
A wound management/treatment form with the dressing plan (as per the random allocation) was included within the patient’s ward clinical documents. If the dressing required changing before the RA visit, the ward nursing staff would change the dressing as per the plan and document this on the wound management/treatment form (in accordance with the Hospital Wound Management Procedure). They had an additional step to call and advice the Research Team of this dressing change. Both the recording on the wound management/treatment form and call to the Research Team were used as strategies to assess adherence to the dressing plan.
Intervention code [1] 325038 0
Treatment: Devices
Comparator / control treatment
This study compared patients skin tear healing outcomes in the use of two differing wound dressing products using an Adhesive silicone foam dressing (Mepilex Border) as the comparator dressing.
Control group
Active

Outcomes
Primary outcome [1] 333341 0
The primary outcome is the is Skin Tear Healing, this is a clinical determination based on a composite assessment of skin flap quality, epithelial and granulation tissue regeneration.
Timepoint [1] 333341 0
Assessments will be undertaken after wound cleansing and prior to dressing application on day of recruitment, then at day 7, day 14 and finally day 21.
Secondary outcome [1] 416678 0
Dressing product ‘fit for purpose’: ease of application. Assessed using likert scale.
Timepoint [1] 416678 0
Assessments will be undertaken on day of recruitment, then at day 7, day 14 and finally day 21, post-dressing application.
Secondary outcome [2] 418673 0
Dressing product ‘fit for purpose’: maintains its integrity Assessed was dressing intact at review.
Timepoint [2] 418673 0
Assessments will be undertaken post recruitment at day 7, then at day 14 and finally day 21, prior to old dressing removal and wound cleansing.
Secondary outcome [3] 418675 0
Dressing product ‘fit for purpose’: manages exudate. Assessed using likert scale
Timepoint [3] 418675 0
Assessments will be undertaken post recruitment at day 7, then at day 14 and finally day 21, prior to old dressing removal and wound cleansing.
Secondary outcome [4] 418679 0
Patient experience: wound pain. Assessed using verbal response on pain scale 0 (no pain) to 10 (worst) pain can imagine.
Timepoint [4] 418679 0
Assessments will be undertaken on day of recruitment, then at day 7, day 14 and finally day 21, post-dressing application.
Secondary outcome [5] 418680 0
Patient experience: comfort of dressing. Assessed using likert scale.
Timepoint [5] 418680 0
Assessments will be undertaken on day of recruitment, then at day 7, day 14 and finally day 21, post-dressing application.
Secondary outcome [6] 418681 0
Patient experience: effects on activities of daily activities. Assessed using likert scale.
Timepoint [6] 418681 0
Assessments will be undertaken on day of recruitment, then at day 7, day 14 and finally day 21, post-dressing application.
Secondary outcome [7] 418682 0
Patient experience: overall satisfaction of the product
Timepoint [7] 418682 0
Assessments will be undertaken on day of recruitment, then at day 7, day 14 and finally day 21, post-dressing application.

Eligibility
Key inclusion criteria
Skin tears occurring on the arms
Skin Tear STAR category 1A, 1B, 2A, 2B, 3
Skin tears equal to or less than 100 cm2 area
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Skin Tear that are older than 72 hours
Skin tears occurring on other parts of the body
Patients unable attend follow-up
Patients with uncontrolled bleeding
Patients with a clot beneath the skin flap which is unable to be evacuated

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed if it was done by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator was used to allocate participants to the 2 treatment arms.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data will be entered into SPSS Version 19 for analysis. Descriptive statistics will be used to describe the sample and inferential statistics will be used to analyse differences and relationships in the data. Significance is set at p<0.05

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
12/11/2013
Date of last participant enrolment
Anticipated
Actual
13/02/2020
Date of last data collection
Anticipated
Actual
19/02/2020
Sample size
Target
126
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23701 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 39136 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 312786 0
Charities/Societies/Foundations
Name [1] 312786 0
The Prince Charles Hospital Foundation
Country [1] 312786 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
627 Rode Road, Chermside, Qld 4032
Country
Australia
Secondary sponsor category [1] 314483 0
University
Name [1] 314483 0
Australian Catholic University
Address [1] 314483 0
1100 Nudgee Rd, Banyo QLD 4014
Country [1] 314483 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312076 0
The Prince Charles Hospital, Metro North Hospital and Health Service, Human Research Ethics Committee
Ethics committee address [1] 312076 0
627 Rode Road, Chermside, Qld 4032
Ethics committee country [1] 312076 0
Australia
Date submitted for ethics approval [1] 312076 0
27/02/2013
Approval date [1] 312076 0
26/04/2013
Ethics approval number [1] 312076 0
HREC-13QPCH-69

Summary
Brief summary
Brief summary: The purpose of this pilot study is to assess Skin Tear healing trends with the use of two differing wound dressing types (adhesive silicone foam dressing versus meshed silicone interface dressing), the dressing performance outcomes and the patient and staff satisfaction with the use of these two products. These two products are currently in use for the treatment of Skin Tears within the TPCH based on a standardised treatment regime. This regime is based on best available evidence, which included expert opinion and a regime generated by a dressing product manufacturer. Although the two options are based on a review of the evidence, there is minimal evidence in regards to their skin tear treatment efficacy. In practice, the decision to use one or the other is based on individual staff preference. The hypothesis is that one of the dressings advantages versus disadvantages, in comparison to the alternative will result in improved healing outcomes, patient and staff satisfaction. The design of the study is a randomised study of TPCH patients sustaining upper limb skin tears. A consecutive, convenience sample of 126 adults (aged 18 or over) will be recruited. Following consent patients will be randomised into two treatment arms with their Skin Tears dressed either with the adhesive silicone foam dressing or the meshed silicone interface dressing. Baseline data will be collected when the skin tear is first assessed and dressed, with follow up data will be collected at 7 days, 14 days, and 21 days.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123382 0
Mr Damian Williams
Address 123382 0
The Prince Charles Hospital
Wound/Stoma Service
627 Rode Road
Chermside, Qld 4032
Country 123382 0
Australia
Phone 123382 0
+61 7 31395646
Fax 123382 0
Email 123382 0
damian.williams@health.qld.gov.au
Contact person for public queries
Name 123383 0
Mr Damian Williams
Address 123383 0
The Prince Charles Hospital
Wound/Stoma Service
627 Rode Road
Chermside, Qld 4032
Country 123383 0
Australia
Phone 123383 0
+61 7 31395646
Fax 123383 0
Email 123383 0
damian.williams@health.qld.gov.au
Contact person for scientific queries
Name 123384 0
Prof Paul Fulbrook
Address 123384 0
The Prince Charles Hospital
Nursing Research & Practice Development Centre
627 Rode Road
Chermside, Qld 4032
Country 123384 0
Australia
Phone 123384 0
+61 731394087
Fax 123384 0
Email 123384 0
Paul.Fulbrook@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data that support the findings of this study are not publicly available due to privacy or ethical restrictions.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17856Ethical approval    385081-(Uploaded-17-02-2023-16-08-20)-Study-related document.pdf
18103Study protocol    385081-(Uploaded-24-01-2023-12-06-27)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.