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Trial registered on ANZCTR

Registration number

ACTRN12620001207909

Ethics application status

Approved

Date submitted

18/09/2020

Date registered

13/11/2020

Date last updated

13/11/2020

Date data sharing statement initially provided

13/11/2020

Date results provided

13/11/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Topical Skin Adhesive versus Nylon Sutures For Incision Closure In Forefoot Surgery: A Randomised Controlled Trial

Scientific title

A single blinded, prospective randomised controlled trial of evaluation of wound healing and pain at post-operative dressing change between skin closure with synthetic polybutester sutures and octyl cyanoacrylate tissue adhesive in patients who have elective open forefoot surgery

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1258-4232

Trial acronym

STICS

Linked study record

Health condition

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

Elective forefoot surgery

hallux valgus

First Metatarsophalangeal joint fusion

Condition category

Condition code

Surgery

Surgical techniques

Skin

Normal skin development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention: skin closure reinforcement with 2- Octyl-cyanoacrylate tissue adhesive following subcuticular skin closure with absorbable 3.0 vicryl rapide following elective open forefoot surgery (either hallux valgus correction or first MTP arthrodesis). All wound closure (in either group) was conducted by a single surgeon (the Principal Investigator, an orthopaedic foot and ankle surgeon). Study data including intervention type was entered into a study-specific database following the intervention. Adherence was confirmed at the pre-specified follow up times.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Control : skin closure reinforcement with synthetic polybutester sutures following subcuticular skin closure with absorbable 3.0 vicryl rapide following elective open forefoot surgery (either hallux valgus correction or first MTP arthrodesis)

Control group

Active

Outcomes

Primary outcome [1]

Visual analogue scale for pain

Timepoint [1]

two weeks following surgery

Secondary outcome [1]

Wound evaluation using validated wound evaluation score (Modified Hollander Wound Score)

Timepoint [1]

two weeks following surgery

Secondary outcome [2]

Time taken for each method of skin closure. This was measured using a digital stopwatch and recorded on each CRF and entered onto the study database following each operation

Timepoint [2]

At the time of surgery

Secondary outcome [3]

Time taken to undergo dressing change in first outpatient clinic appointment. This was measured using a digital stopwatch and recorded on each CRF and entered onto the study database following each operation

Timepoint [3]

Two weeks following surgery

Secondary outcome [4]

Patient satisfaction with incision cosmesis. This was measured using a 5-point Likert Scale: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied

Timepoint [4]

six weeks following surgery

Eligibility

Key inclusion criteria

The inclusion criteria for this study were:
- Age greater than 18 years
- Undergoing elective open forefoot surgery; either Scarf ± Akin osteotomy for hallux valgus or first metatarsophalangeal joint arthrodesis)
- Informed consent for participation in the RCT

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

The exclusion criteria for this study were:
- Revision forefoot surgery
- Percutaneous forefoot surgery
- Patients undergoing surgery not involving the first ray
- Cognitive impairment preventing patient from adhering to post operative instructions or completing patient reported outcome scores

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 concealment was performed using sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation was carried out be by block permuted computer generated method with sealed envelopes being used to choose grouping. Each patient was randomised in theatre into either the intervention or control group.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

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

The independent t-test for parametric data was used to compare continuous variables. Fisher’s exact test and chi-squared analysis were used to assess categorical variables. All statistical analyses were performed using the Python SciPy package2. Statistical significance was defined as a P value of less than 0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

31/01/2018

Date of last participant enrolment

Anticipated

Actual

24/10/2018

Date of last data collection

Anticipated

Actual

5/12/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Friends of the Mater Foundation

Address [1]

The Friends of the Mater Foundation
PO Box 958,
North Sydney,
NSW 2059
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Hospital Sydney

Address

St Vincent's Hospital Sydney
390 Victoria Street,
Darlinghurst,
NSW 2010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Human Research Ethics Committee

Ethics committee address [1]

St Vincent's Hospital Sydney,
390 Victoria Street,
Darlinghurst,
NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/05/2017

Approval date [1]

09/05/2017

Ethics approval number [1]

SVH File no 17/063, National Ethics Application Form AU/1/94FB24

Summary

Brief summary

Postoperative infections are the most common cause of complications in surgical patients and result in an average increase of four days in the hospital. Foot and ankle surgery may have a higher infection rate than other surgical areas since surgical preparation cannot fully reduce the bacterial load prior to incision. Due to the increased rate of infection and wound breakdown surgeons routinely reinforce absorbable subcuticular wound closures with non-absorbable skin sutures. Removal of these sutures can be painful and leave unsightly scars.

2- Octyl-cyanoacrylate tissue adhesive is available in Australia as an alternative to skin suturing for wound closure. There have been mixed results with this product with some studies showing good wound closure and low infection rates and others showing high rates of wound dehiscence and infection. The high rates of wound dehiscence with tissue adhesive has been postulated to be due to high wound tension.

We believe that tissue adhesive may be successful an occlusive reinforcement after proper skin closure with appropriate methods to reduce tension such as subcuticular stitching. There have been no studies looking at using tissue adhesive in this fashion in foot and ankle surgery. The hypothesis of this study is that using tissue adhesive rather than non absorbable sutures to reinforce forefoot wounds will reduce patient pain and anxiety at dressing change whilst not affecting the quality of wound healing. The study will be powered to assess these two parameters.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Andrew Wines

Address

North Sydney Orthopaedics and Sports Medicine Centre
Suite G02, Mater Clinic, 3 Gillies Street, Wollstonecraft NSW 2065, AUSTRALIA

Country

Australia

Phone

+61 294090500

Fax

Andrew@drapwines.com.au

Contact person for public queries

Name

Robbie Ray

Address

Princess Royal University Hospital, King's College Hospital NHS Foundation trust,
Farnborough Common,
Orpington,
BR6 8ND

Country

United Kingdom

Phone

+441689 863000

Fax

robbie.ray2@nhs.net

Contact person for scientific queries

Name

Robbie Ray

Address

Princess Royal University Hospital, King's College Hospital NHS Foundation trust,
Farnborough Common,
Orpington,
BR6 8ND

Country

United Kingdom

Phone

+441689 863000

Fax

robbie.ray2@nhs.net

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Patients were not consented for their individual participant data to be made available to others beyond this specific trial there

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
9211	Other		This study is being prepared for submission to a p... [More Details]
9212	Ethical approval	robbie.ray2@nhs.net	Please email if you would like a copy of the ethic... [More Details]
9213	Study protocol	robbie.ray2@nhs.net	Please email if you would like a copy of the study... [More Details]
9215	Informed consent form	robbie.ray2@nhs.net	Please email if you would like a copy of the patie... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Randomized Controlled Trial of Topical Skin Adhesive vs Nylon Sutures for Incision Closure in Forefoot Surgery.	2021	https://dx.doi.org/10.1177/10711007211002501

N.B. These documents automatically identified may not have been verified by the study sponsor.

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