Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001030965
Ethics application status
Approved
Date submitted
20/09/2011
Date registered
28/09/2011
Date last updated
8/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
V-Loc 90 Absorbable Wound Closure device vs. Monocryl absorbable sutures for wound closure.
Scientific title
Barbed skin suture wound closure: A prospective, randomised comparison of barbed vs monofilament
polyglyconate synthetic absorbable sutures in elective surgery.
Secondary ID [1] 263075 0
HREC/11/PH/44
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound closure 270822 0
Condition category
Condition code
Surgery 271009 271009 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients fitting the inclusion criteria will have one side of their wound closed using the V- Loc absorbable suture and the other side of the one wound closed with Monocryl absorbable suture. Preliminary data indicates that this will take less than 30 minutes. Wounds will be assessed at one, six and twelve weeks to assess healing and any complications. Photographs will be taken of the wound and scar cosmesis assessed by an independant blinded plastic surgeon.
Intervention code [1] 269429 0
Treatment: Surgery
Comparator / control treatment
One side of the wound will be closed using the V- Loc absorbable suture and the other side of the one wound closed with Monocryl absorbable suture. The v-loc suture is has unidirectional shallow barbs which distributes tension throughout the wound and allows closure of the wound without the tying of knots.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279669 0
Surgery time
Timepoint [1] 279669 0
Time taken to close the wound using each type of suture.
Primary outcome [2] 279682 0
Scar cosmesis. Photographs of scars at the given timepoints will be assessed by a blinded independant plastic surgeon/s. Scars will be scored using the modified Hollander cosmesis score
Timepoint [2] 279682 0
Scar cosmesis assessed after one week, six weeks and 12 weeks.
Secondary outcome [1] 294163 0
Wound discharge +/- infection. Any discharge will be sent for microbial testing. Any use of antibiotics to treat infections will be noted.
Timepoint [1] 294163 0
Assessed at one, six and twelve weeks after surgery. Any discharge will be sent for microbial testing.
Secondary outcome [2] 294199 0
Wound redness. This will be assessed visually as per routine outpatient assessment
Timepoint [2] 294199 0
Assessed at one, six and twelve weeks after surgery.

Eligibility
Key inclusion criteria
Elective reconstruction surgery
18 years or older.
In overall good health.
Elective reconstructive surgery (abdominoplasty or autologous breast reconstruction).
American Society of Anesthesiology (ASA) class 1 or 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous allergic reaction to synthetic suture materials,
Diabetes,
concominant use of steroid medication,
Skin sepsis or systemic fever,
BMI > 35,
History of keloid or hypertrophic scar formation or
other dermatologic conditions known to impair
wound healing,
History of immunosuppressive drug use,
History of chronic alcohol or drug abuse within the
past 1 year,
American Society of Anesthesiology (ASA) class 3 or 4

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Toss of a coin will determine on which side to use V-Loc and Monocryl
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269902 0
Hospital
Name [1] 269902 0
Peninsula Health
Country [1] 269902 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Department of Surgery (Plastic and Reconstructive Surgery)
PO Box 52
Frankston VIC 3052
Country
Australia
Secondary sponsor category [1] 268913 0
None
Name [1] 268913 0
Address [1] 268913 0
Country [1] 268913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271873 0
Peninsula Health - Health Human Research Ethics Committee
Ethics committee address [1] 271873 0
c/- Peninsula Health Research Department
PO Box 192
Mt Eliza VIC 3930
Ethics committee country [1] 271873 0
Australia
Date submitted for ethics approval [1] 271873 0
16/06/2011
Approval date [1] 271873 0
Ethics approval number [1] 271873 0
HREC/11/PH/44

Summary
Brief summary
Patients fitting the inclusion criteria will be consented. Half their wound will be stitched with a barbed suture (v-Loc) and the other half of their wound will be stiched using a traditional monocryl suture . The wound will be assessed at one, six and twelve weeks after wound closure. Photographs of the wound at these times will be assessed by a blinded independant plastic surgeon to rate wound cosmesis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33186 0
Address 33186 0
Country 33186 0
Phone 33186 0
Fax 33186 0
Email 33186 0
Contact person for public queries
Name 16433 0
Ms Lee-Anne Clavarino
Address 16433 0
Research Department
Peninsula Health
PO Box 192
Mount Eliza VIC 3930
Country 16433 0
Australia
Phone 16433 0
61 3 9788 1473
Fax 16433 0
Email 16433 0
[email protected]
Contact person for scientific queries
Name 7361 0
Mr David Hunter-Smith
Address 7361 0
Department of Surgery
Frankston Hospital
PO Box 52
Frankston VIC 3199
Country 7361 0
Australia
Phone 7361 0
61 3 9784 7368
Fax 7361 0
61 3 9784 7568
Email 7361 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.