Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001924246p
Ethics application status
Submitted, not yet approved
Date submitted
20/11/2018
Date registered
27/11/2018
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Closing the Gap: A prospective, single-blind randomised controlled trial for subcutaneous fat closure in hip arthroplasty
Scientific title
Closing the Gap: A prospective, single-blind randomised controlled trial for subcutaneous fat closure in hip arthroplasty
Secondary ID [1] 296653 0
None
Universal Trial Number (UTN)
U1111-1224-2458
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Replacement 310480 0
Wound Closure 310481 0
Condition category
Condition code
Surgery 309193 309193 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a two-armed study comparing methods of fat layer closure during hip replacement. Participants enrolled in the trial will be randomised to have their fat layer closed with either Glubran 2 surgical adhesive or 1 Vicryl sutures.

Both interventions will be performed by the operative orthopaedic surgeon who has 10 years' experience.

The one intervention will be performed per participant in the operating theatres at Linacre Private Hospital.

Arm 1:
Intervention - Glubran 2 surgical adhesive
Description - This is a synthetic cyanoacrylate glue that is biodegradable, TGA approved for use on internal tissues. It is manufactured by GEM in Italy and distributed by Matrix Surgical in Australia.
Procedure - During closure of the subcutaneous fat layer, 1mL of Glubran 2 will be evenly applied to the fat layer and deep fascia, deep to the dermal tissue using a spray applicator. The wound edges will be approximated for 90 seconds to allow the tissue adhesive to work. The dermal and epidermal layers will be everted to ensure they are not glued.

Arm 2:
Intervention - 1 Vicryl sutures
Description - This is a biodegradable polyglactin suture, TGA approved for tissue approximation. It is manufactured and distributed by Ethicon.
Procedure - During closure of the subcutaneous fat layer, the subcutaneous fat will be closed using interrupted 1 vicryl sutures spread approximately 3cm apart spanning the length of the wound. Sutures will be tensioned appropriately to oppose the layer while avoiding damage to the tissue and subsequent fat necrosis.

For both interventional arms:
The dermal and subcuticular layers will be closed with running dissolvable 2.0 vicryl and 3.0 stratafix sutures respectively. Tiss2 tissue adhesive (Matrix Surgical; GEM, Italy) will be applied to the wound and allowed to dry prior to application of a waterproof dressing.
Intervention code [1] 312958 0
Treatment: Surgery
Intervention code [2] 313023 0
Treatment: Other
Comparator / control treatment
Intervention - 1 Vicryl sutures
Description - This is a biodegradable polyglactin suture, TGA approved for tissue approximation. It is manufactured and distributed by Ethicon.
Procedure - During closure of the subcutaneous fat layer, the subcutaneous fat will be closed using interrupted 1 vicryl sutures spread approximately 3cm apart spanning the length of the wound. Sutures will be tensioned appropriately to oppose the layer while avoiding damage to the tissue and subsequent fat necrosis.
Control group
Active

Outcomes
Primary outcome [1] 308169 0
Volume (measured in mm cubed) of superficial fluid collection in the subcutaneous fat layer measured using ultrasonography.
Timepoint [1] 308169 0
At 10 to 20 days post-operatively (Timed for the participant's usual wound review with the operative surgeon).
Primary outcome [2] 308170 0
Incidence (percentage) of participants that have a superficial fluid collection in the subcutaneous fat layer measured using ultrasonography.
Timepoint [2] 308170 0
At 10 to 20 days post-operatively (Timed for the participant's usual wound review with the operative surgeon).
Secondary outcome [1] 354141 0
Participant reported pain score using a visual analogue scale from 0 (no pain) to 10 (extreme pain)
Timepoint [1] 354141 0
10 to 20 days post-operatively, immediately prior to ultrasonography.
Secondary outcome [2] 354142 0
Haemoglobin change from pre-operative to day 1 post-operative, measured in decilitres. This will be measured using a full blood count in the pathology laboratory.
Timepoint [2] 354142 0
Measured one day after hip replacement and intervention
Secondary outcome [3] 354143 0
Post-operative complications. Major complications will be defined as anaphylaxis, prosthetic joint infection, or other complications requiring surgical intervention, intravenous antibiotic therapy or blood transfusion. Minor complications will be defined as wound ooze requiring dressing change or negative pressure dressing therapy, superficial infection requiring oral antibiotic therapy, localized allergic reactions or delayed wound healing. This outcome will be assessed in a multi-factorial way dependent on the complication of concern. This will include clinical examination, radiological tests such as X-Ray or MRI and pathology tests including biochemical or haematological (inflammatory markers).
Timepoint [3] 354143 0
6 to 8 weeks post-operatively. Any complications noted in trial patients after this follow-up period will still be recorded in the study.

Eligibility
Key inclusion criteria
All patients planned for total hip arthroplasty by a single surgeon (Chris Jones) at the institution will be eligible for the study. (Linacre Private Hospital)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery on the affected hip
Contraindication to tissue adhesive use
Wounds that cannot be primarily closed or require a negative pressure dressing

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)
Participants will be allocated to an intervention using block randomisation software on a computer, performed by the orthopaedic registrar at the institution after inclusion to the study by the operative surgeon.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be performed by permuted block randomisation using computer software. The block size will be 5.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was performed to determine a sample size of 20 participants in each study arm to provide 90% power to detect a 50% reduction in the presence of superficial fluid accumulation. This was estimated from studies of tissue adhesive and negative pressure dressing therapy, accounting for the incidence of seroma formation and estimated intervention efficacy.

A biostatistician will be used to analyse the data, to perform a Student's T-Test to analyse the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2019
Actual
Date of last participant enrolment
Anticipated
4/05/2020
Actual
Date of last data collection
Anticipated
6/07/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12449 0
Linacre Private Hospital - Hampton
Recruitment postcode(s) [1] 24733 0
3188 - Hampton

Funding & Sponsors
Funding source category [1] 301233 0
Commercial sector/Industry
Name [1] 301233 0
Matrix Surgical
Country [1] 301233 0
Australia
Primary sponsor type
Individual
Name
Edward O'Bryan
Address
Linacre Private Hospital, 12 Linacre Road, Hampton 3188, Victoria
Country
Australia
Secondary sponsor category [1] 300864 0
Individual
Name [1] 300864 0
Chris Jones
Address [1] 300864 0
Linacre Private Hospital, 12 Linacre Road, Hampton 3188, Victoria
Country [1] 300864 0
Australia
Secondary sponsor category [2] 300867 0
Individual
Name [2] 300867 0
Jane Mitchell
Address [2] 300867 0
MIA Radiology, Linacre Private Hospital, 12 Linacre Road, Hampton 3188, Victoria
Country [2] 300867 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301973 0
Belberry Limited
Ethics committee address [1] 301973 0
Ethics committee country [1] 301973 0
Australia
Date submitted for ethics approval [1] 301973 0
21/09/2018
Approval date [1] 301973 0
Ethics approval number [1] 301973 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88726 0
Dr Edward O' Bryan
Address 88726 0
Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria
Country 88726 0
Australia
Phone 88726 0
+61 431532539
Fax 88726 0
Email 88726 0
[email protected]
Contact person for public queries
Name 88727 0
Edward O' Bryan
Address 88727 0
Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria
Country 88727 0
Australia
Phone 88727 0
+61 431532539
Fax 88727 0
Email 88727 0
[email protected]
Contact person for scientific queries
Name 88728 0
Edward O' Bryan
Address 88728 0
Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria
Country 88728 0
Australia
Phone 88728 0
+61 431532539
Fax 88728 0
Email 88728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All participant data after de-identification.
When will data be available (start and end dates)?
Immediately following publication with no end-date.
Available to whom?
Available on a case-by-case basis at the principle investigator's discretion in discussion with the other investigators.
Available for what types of analyses?
For IPD meta-analysis.
How or where can data be obtained?
Access subject to approval by the investigators.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
344Study protocol    376417-(Uploaded-20-11-2018-10-49-33)-Study-related document.docx
345Informed consent form    376417-(Uploaded-20-11-2018-10-49-53)-Study-related document.docx



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.