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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]

None

Universal Trial Number (UTN)

U1111-1224-2458

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hip Replacement

Wound Closure

Condition category

Condition code

Surgery

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]

Treatment: Surgery

Intervention code [2]

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]

Volume (measured in mm cubed) of superficial fluid collection in the subcutaneous fat layer measured using ultrasonography.

Timepoint [1]

At 10 to 20 days post-operatively (Timed for the participant's usual wound review with the operative surgeon).

Primary outcome [2]

Incidence (percentage) of participants that have a superficial fluid collection in the subcutaneous fat layer measured using ultrasonography.

Timepoint [2]

At 10 to 20 days post-operatively (Timed for the participant's usual wound review with the operative surgeon).

Secondary outcome [1]

Participant reported pain score using a visual analogue scale from 0 (no pain) to 10 (extreme pain)

Timepoint [1]

10 to 20 days post-operatively, immediately prior to ultrasonography.

Secondary outcome [2]

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]

Measured one day after hip replacement and intervention

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Linacre Private Hospital - Hampton

Recruitment postcode(s) [1]

3188 - Hampton

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Matrix Surgical

Address [1]

Unit 5/200 Wellington Rd Clayton VIC 3168

Country [1]

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]

Individual

Name [1]

Chris Jones

Address [1]

Linacre Private Hospital, 12 Linacre Road, Hampton 3188, Victoria

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Jane Mitchell

Address [2]

MIA Radiology, Linacre Private Hospital, 12 Linacre Road, Hampton 3188, Victoria

Country [2]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Belberry Limited

Ethics committee address [1]

129 Glen Osmond Road, Eastwood, 5063, Adelaide, South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/09/2018

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This is a randomised controlled trial of 40 consecutive patients undergoing elective total hip arthroplasty. The aim is evaluate the use of a tissue adhesive (Glubran 2, Matrix Surgical) for subcutaneous fat closure. Participants will be randomised to have their fat layer closed with either a tissue adhesive or dissolvable sutures. The participants will undergo an ultrasound at day 10 to 20 post-operatively to assess the degree of fluid accumulation in the fat layer. Outcomes will include the incidence and magnitude of superficial seroma, participant reported pain scores, blood loss and incidence of wound complications.
We hypothesise that subcutaneous fat closed with the glue will have less fluid accumulation which may be a precursor to infection.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Edward O' Bryan

Address

Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria

Country

Australia

Phone

+61 431532539

Fax

[email protected]

Contact person for public queries

Name

Edward O' Bryan

Address

Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria

Country

Australia

Phone

+61 431532539

Fax

[email protected]

Contact person for scientific queries

Name

Edward O' Bryan

Address

Linacre Private Hospital, 12 Linacre Road, Hampton, 3188, Victoria

Country

Australia

Phone

+61 431532539

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Available on a case-by-case basis at the principle investigator's discretion in discussion with the other investigators.

Conditions for requesting access:
• -

What individual participant data might be shared?

• All participant data after de-identification.

What types of analyses could be done with individual participant data?

• For IPD meta-analysis.

When can requests for individual participant data be made (start and end dates)?

From:
Immediately following publication with no end-date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approval by the investigators.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
344	Study protocol					Study-related document.docx
345	Informed consent form					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.

Trial Review

Documents added manually

Documents added automatically