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Trial registered on ANZCTR


Registration number
ACTRN12609000567224
Ethics application status
Not yet submitted
Date submitted
30/06/2009
Date registered
10/07/2009
Date last updated
10/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled double blinded trial of the use of cold scalpel versus cutting diathermy for skin incisions in clean (non-bowel) laparoscopic and open surgery
Scientific title
Randomised controlled double blinded trial comparing cosmesis and wound healing of skin incisions in clean (non-bowel) laparoscopic and open surgery using cold scalpel versus cutting diathermy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
surgical skin incisions - wound healing and cosmesis 237121 0
Condition category
Condition code
Surgery 237447 237447 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Skin incisions made using a flat, blunt-tipped stainless steel diathermy blade transmitting 30W pure cutting current. Cutting effect is produced by vapourising cells. Procedure requires only a few seconds.
Intervention code [1] 236842 0
Treatment: Surgery
Comparator / control treatment
Skin incisions made by stainless steel cold scalpel (sharpened edge) used to physically cut the skin. Procedure takes only a few seconds
Control group
Active

Outcomes
Primary outcome [1] 238249 0
Participant satisfaction with wound (cosmesis). This will be assessed on a visual analogue scale.
Timepoint [1] 238249 0
1 week and 1 month after surgery
Primary outcome [2] 238250 0
clinician assessment of wound (cosmesis). This will also be assessed using a visual analogue scale
Timepoint [2] 238250 0
1 week and 1 month after surgery
Secondary outcome [1] 244587 0
wound infection by clinician assessment at review appointments
Timepoint [1] 244587 0
1 week and 1 month after surgery
Secondary outcome [2] 244588 0
delayed healing by clinician assessment at review appointments
Timepoint [2] 244588 0
1 week and 1 month after surgery

Eligibility
Key inclusion criteria
Adult patients presenting to a single surgeon's rooms who are subsequently booked for elective clean (non-bowel) laparoscopic or open surgery (by the same surgeon)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
malignancy;
connective tissue disease;
immunocompromised patients;
diabetes mellitus;
bleeding disorders;
previous history of keloid/hypertrophic; scarring;
existing skin disease, open wounds on abdomen;
previous surgical wound infection following abdominal surgery;
obesity - defined as Body Mass Index (BMI) greater than 35;
smoking

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)
Potential participants will be recruited from surgeon's rooms.
Once enrolled, the participant will be randomly assigned to one of two groups. A sealed envelope will be attached to the participant's consent form. This envelope will contain a paper labelled with "knife" or "diathermy", drawn from a box containing an equal number of each (identical from the exterior). The participant will not be informed which group they are assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sealed envelope containing label with "knife" or "diathermy", drawn from a box containing equal number of each
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237232 0
Self funded/Unfunded
Name [1] 237232 0
Country [1] 237232 0
Primary sponsor type
Hospital
Name
Alfred Health
Address
Commercial Road
Melbourne
Victoria 3004
Australia
Country
Australia
Secondary sponsor category [1] 236721 0
Hospital
Name [1] 236721 0
Peninsula Health
Address [1] 236721 0
Hastings Road
Frankston
Victoria 3199
Country [1] 236721 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239332 0
Alfred Health
Ethics committee address [1] 239332 0
Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 239332 0
Australia
Date submitted for ethics approval [1] 239332 0
02/07/2009
Approval date [1] 239332 0
Ethics approval number [1] 239332 0
1/09/0137

Summary
Brief summary
The skin incisions to perform common surgical procedures can be made using a traditional steel knife blade (cold scalpel) or “electric knife” (cutting diathermy), which is a blunt electrode transmitting electric current to divide the skin. Despite both these methods being in use for many years, to date we have found very little convincing evidence that one is better than the other. Thus the choice of method used is often made on surgeon preference alone. Some surgeons are using both methods interchangeably in routine practice.

We are conducting a trial which aims to determine whether one modality is superior to the other in terms of wound healing and infection. In this era of increasing awareness and prevention of blood-borne infection transmission, alternatives to the use of sharp instruments such as the traditional cold scalpel are continually being sought. If both methods are shown to produce similar results, the blunt cutting diathermy could provide a much safer alternative to the traditional sharp cold scalpel.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29820 0
Address 29820 0
Country 29820 0
Phone 29820 0
Fax 29820 0
Email 29820 0
Contact person for public queries
Name 13067 0
Ms Rowan Frew
Address 13067 0
Research and Ethics Unit, The Alfred
Commercial Road
Melbourne
Victoria 3004
Country 13067 0
Australia
Phone 13067 0
+61 3 9076 3848
Fax 13067 0
Email 13067 0
[email protected]
Contact person for scientific queries
Name 3995 0
Dr Vivian Wai-Ling Yu
Address 3995 0
Commercial Road
Melbourne
Victoria 3004
Country 3995 0
Australia
Phone 3995 0
+61 3 9076 2000
Fax 3995 0
Email 3995 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

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