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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 information initially 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] 302350 0
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 319124 0
hallux valgus 319125 0
First Metatarsophalangeal joint fusion 319126 0
Condition category
Condition code
Surgery 317086 317086 0 0
Surgical techniques
Skin 317087 317087 0 0
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] 318639 0
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] 325173 0
Visual analogue scale for pain
Timepoint [1] 325173 0
two weeks following surgery
Secondary outcome [1] 387083 0
Wound evaluation using validated wound evaluation score (Modified Hollander Wound Score)
Timepoint [1] 387083 0
two weeks following surgery
Secondary outcome [2] 387084 0
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] 387084 0
At the time of surgery
Secondary outcome [3] 387085 0
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] 387085 0
Two weeks following surgery
Secondary outcome [4] 387086 0
Patient satisfaction with incision cosmesis. This was measured using a 5-point Likert Scale: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied
Timepoint [4] 387086 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306779 0
Charities/Societies/Foundations
Name [1] 306779 0
The Friends of the Mater Foundation
Address [1] 306779 0
The Friends of the Mater Foundation
PO Box 958,
North Sydney,
NSW 2059
Australia
Country [1] 306779 0
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] 307331 0
None
Name [1] 307331 0
None
Address [1] 307331 0
Country [1] 307331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306942 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 306942 0
St Vincent's Hospital Sydney,
390 Victoria Street,
Darlinghurst,
NSW 2010
Ethics committee country [1] 306942 0
Australia
Date submitted for ethics approval [1] 306942 0
04/05/2017
Approval date [1] 306942 0
09/05/2017
Ethics approval number [1] 306942 0
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 105526 0
Mr Andrew Wines
Address 105526 0
North Sydney Orthopaedics and Sports Medicine Centre
Suite G02, Mater Clinic, 3 Gillies Street, Wollstonecraft NSW 2065, AUSTRALIA
Country 105526 0
Australia
Phone 105526 0
+61 294090500
Fax 105526 0
Email 105526 0
Andrew@drapwines.com.au
Contact person for public queries
Name 105527 0
Mr Robbie Ray
Address 105527 0
Princess Royal University Hospital, King's College Hospital NHS Foundation trust,
Farnborough Common,
Orpington,
BR6 8ND
Country 105527 0
United Kingdom
Phone 105527 0
+441689 863000
Fax 105527 0
Email 105527 0
robbie.ray2@nhs.net
Contact person for scientific queries
Name 105528 0
Mr Robbie Ray
Address 105528 0
Princess Royal University Hospital, King's College Hospital NHS Foundation trust,
Farnborough Common,
Orpington,
BR6 8ND
Country 105528 0
United Kingdom
Phone 105528 0
+441689 863000
Fax 105528 0
Email 105528 0
robbie.ray2@nhs.net

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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?
Study protocol
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 9211 0
Other
Citation [1] 9211 0
Link [1] 9211 0
Email [1] 9211 0
Other [1] 9211 0
This study is being prepared for submission to a peer-reviewed orthopaedic journal where it will be accessible.
Attachment [1] 9211 0
Type [2] 9212 0
Ethical approval
Citation [2] 9212 0
Link [2] 9212 0
Email [2] 9212 0
robbie.ray2@nhs.net
Other [2] 9212 0
Please email if you would like a copy of the ethical approval
Attachment [2] 9212 0
Type [3] 9213 0
Study protocol
Citation [3] 9213 0
Link [3] 9213 0
Email [3] 9213 0
robbie.ray2@nhs.net
Other [3] 9213 0
Please email if you would like a copy of the study protocol
Attachment [3] 9213 0
Type [4] 9215 0
Informed consent form
Citation [4] 9215 0
Link [4] 9215 0
Email [4] 9215 0
robbie.ray2@nhs.net
Other [4] 9215 0
Please email if you would like a copy of the patient consent form
Attachment [4] 9215 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 9464 0
Presentation
Citation/DOI/link/details [1] 9464 0
Poster presentation at BOFAS Annual Meeting November 13-15 2019
ePoster presentation at AOFAS Virtual Annual Meeting September 10-12 2020
Attachments [1] 9464 0
Results – basic reporting
Results – plain English summary