Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000483954
Ethics application status
Approved
Date submitted
1/04/2011
Date registered
10/05/2011
Date last updated
10/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised trial of different stitching techniques for skin surgery.
Scientific title
Randomised comparison trial of superficial dermal Maxon suture with Fixomull closure vs standard deep dermal two layer closure technique vs single layer interrupted nylon closure after elliptical skin excision; scar width and cosmesis at six and twelve months.
Secondary ID [1] 259900 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scarring after standard elliptical skin excision. 265501 0
Condition category
Condition code
Surgery 265654 265654 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Maxon full closure of dermis with fixomull epidermal closure.
Involves closure of all dermal layers with a buried interrupted Maxon suture. Epidermal closure effected with fixomull. Sutures are absorbable and are left in place. Fixomull removed after three weeks.

OR

2. Nylon interrupted closure of all layers.
All skin layers closed with simple interrupted nylon sutures, removed day 7 for wounds on the face, and day 14 for wounds on other areas. After this, fixomull is applied over the wound for three weeks.
Intervention code [1] 264323 0
Treatment: Surgery
Comparator / control treatment
Maxon deep dermal closure with nylon closure superficial skin layers. Involves standard deep dermal interrupted, buried Maxon suture, followed by simple interrupted nylon suture closure of superficial dermal and epidermal layers. Nylon sutures removed day 7 for facial lesions, and day 14 for wounds on other areas. After this, fixomull is applied over the wound for three weeks.
Control group
Active

Outcomes
Primary outcome [1] 262439 0
Scar width. Measured with ruler by two independant assessors, one blinded, one not blinded.
Timepoint [1] 262439 0
Six months
Twelve months
Secondary outcome [1] 273781 0
Scar cosmesis.
Measured with the stony-brook scar scale by two observers, one blinded, one not blinded.
Patients also rating their scars with the patient observer scar scale.
Timepoint [1] 273781 0
Six months
Twelve months

Eligibility
Key inclusion criteria
Simple elliptical skin excision
Adults
Enrolment from all eligible patients attending a skin cancer clinic that have elected to undergo surgical excision of a skin lesion (benign or malignant).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ellipse length <25mm
Dermis too thin for valid comparison
Allergy to materials used

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)
Enrolment from all eligible patients attending a skin cancer clinic that have elected to undergo surgical excision of a skin lesion (benign or malignant).
After enrolment, allocation to each group and allocation to intervention procedure is made. Allocation is provided by contacting on-site reception staff who have control of the randomisation list. Access to this list is password protected and not able to be accessed by the investigator.
Each half of the wound is randomly allocated a procedure or control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator in Microsoft Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Each patient has intervention and control suturing technique in the one wound. Each wound has one half that is a control - ie no wounds were allocated to both intervention procedures.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
186
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264785 0
Self funded/Unfunded
Name [1] 264785 0
Nicholas Bostock-Ling
Country [1] 264785 0
Australia
Primary sponsor type
Individual
Name
Nicholas Bostock-Ling
Address
PO Box 590
Sandgate QLD 4017
Country
Australia
Secondary sponsor category [1] 263900 0
None
Name [1] 263900 0
Address [1] 263900 0
Country [1] 263900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266760 0
Redcliffe-Caboolture Human Research Ethics Committee
Ethics committee address [1] 266760 0
Redcliffe Hospital
Anzac Ave
Redcliffe QLD 4020
Ethics committee country [1] 266760 0
Australia
Date submitted for ethics approval [1] 266760 0
Approval date [1] 266760 0
21/04/2010
Ethics approval number [1] 266760 0
HREC/09/QNRC/67

Summary
Brief summary
There are various suturing techniques used to repair wounds after skin surgery. This study was designed to assess the differences between two of these existing techniques, as well as a 'new' technique in terms of scarring.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32426 0
Address 32426 0
Country 32426 0
Phone 32426 0
Fax 32426 0
Email 32426 0
Contact person for public queries
Name 15673 0
Nicholas Bostock-Ling
Address 15673 0
Skin Alert
Suite 19/ 9 Elizabeth Ave
Clontarf QLD 4019
Country 15673 0
Australia
Phone 15673 0
+61 7 3889 5822
Fax 15673 0
Email 15673 0
[email protected]
Contact person for scientific queries
Name 6601 0
Nicholas Bostock-Ling
Address 6601 0
Skin Alert
Suite 19/ 9 Elizabeth Ave
Clontarf QLD 4019
Country 6601 0
Australia
Phone 6601 0
+61 7 3889 5822
Fax 6601 0
Email 6601 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.