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Trial registered on ANZCTR


Registration number
ACTRN12609000516280
Ethics application status
Approved
Date submitted
29/05/2009
Date registered
30/06/2009
Date last updated
30/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The cosmetic outcome of laparotomy incisions using the diathermy scalpel: a double blinded randomised clinical trial
Scientific title
Do patients requiring laparotomy when incised with diathermy scalpel on cutting current compared with standard scalpel blade have comparable outcome with regards to scar cosmesis?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparotomy scar cosmesis 4881 0
Condition category
Condition code
Surgery 237233 237233 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
creating laparotomy incision on the skin surface using the flat stainless-steel diathermy blade on 40W pure-cutting current. Diathermy blade has blunt tip and produces cutting effect by vaporising cells. Half of the incision is done using the diathermy blade and surface incision time requires only few seconds
Intervention code [1] 236668 0
Treatment: Devices
Comparator / control treatment
standard stainless steel scalpel with sharpened edge physically cuts the skin. Half of the incision is done using this standard scalpel and surface incision time is similar to the diathermy technique of few seconds
Control group
Active

Outcomes
Primary outcome [1] 238048 0
visual analogue scale assessing cosmesis
Timepoint [1] 238048 0
One-off measurement at 60 days following the laparotomy of the last recruited patient.
Secondary outcome [1] 242233 0
Likert scale asessing cosmesis
Timepoint [1] 242233 0
One-off measurement at 60 days following the laparotomy of the last recruited patient.
Secondary outcome [2] 242234 0
wound complications including wound dehiscence, incisional hernia, keloid formation, are recorded based on clinical assessment by surgeon at follow-up. Patients were specifically questioned regarding experiences of chronic pain or altered sensations.
Timepoint [2] 242234 0
throughout the trial for a minimum of 60 days and for up to 720 days following laparotomy

Eligibility
Key inclusion criteria
adults requiring laparotomy for colorectal resection at the John Hunter Hospital, able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous laparotomy scar, patients requiring laparoscopic or laparoscopic-assisted surgery

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)
patients are invited to participate in the trial following the consent for the operation required and are ensured that their participation or refusal of the trial will not affect their treatment. Treatment allocation are based on computer generated sequence to ensure approximately equal number in each group. The allocation is revealed to the surgeon immediately prior to the operation by a third party by referring to the randomisation table.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the sequence is computer generated random numbers that are either odd or even representing the two arms of the randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
each patients served as their own control with the full length of the scar approximately divided by two at the level of the umbilicus. Each patient receive half of the length of the skin incision with diathermy and the other half with standard surgical scalpel. Randomisation determines whether the upper or the lower half receives the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5057 0
Self funded/Unfunded
Name [1] 5057 0
Stehphen Ridley Smith
Country [1] 5057 0
Australia
Primary sponsor type
Individual
Name
Stephen Ridely Smith
Address
Department of Colorectal Surgery, Division of Surgery, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country
Australia
Secondary sponsor category [1] 4566 0
Individual
Name [1] 4566 0
Jenny Yang
Address [1] 4566 0
29 Kalora Crescent, Charlestown, NSW, 2290
Country [1] 4566 0
Australia
Other collaborator category [1] 706 0
University
Name [1] 706 0
University of Newcastle
Address [1] 706 0
University Drive, Callaghan, NSW, 2308
Country [1] 706 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239152 0
Hunter New England Area Health Research Ethics Committee
Ethics committee address [1] 239152 0
Hunter New England Area Health Research Ethics Unit. Administration Building Lookout Road, New Lambton, NSW, 2305
Ethics committee country [1] 239152 0
Australia
Date submitted for ethics approval [1] 239152 0
Approval date [1] 239152 0
01/03/2005
Ethics approval number [1] 239152 0
HNEAHREC 02/10/16/13.05

Summary
Brief summary
The main purpose of the study is to compare the difference, if any, in the appearance of the surgical scar between the the diathermy blade and the standard surgical steel scalpel. The blunt diathermy blade produces a cutting effect by passing electric current and vaporise the skin cells while the standard surgical scalpel physically cuts the skin. Anecdotal experience suggest there is no difference in the appearance of the scar between the two instruments. However, the sharp surgical blade remains in common use, albeit almost exclusively for skin incision only in modern day abdominal surgery, because the general perception is that the diathermy will cause charring of the skin and thus results in poorer scar appearance. The presence of the sharp blade poses significant and potentially avoidable risk of sharps injury to the entire surgical team. The study hypothesis is that there are no visible difference in the appearance of the scar between the diathermy and the scalpel.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29668 0
Address 29668 0
Country 29668 0
Phone 29668 0
Fax 29668 0
Email 29668 0
Contact person for public queries
Name 12915 0
Dr Stephen Smith
Address 12915 0
Department of Colorectal Surgery, Division of Surgery, John Hunter Hospital. Lookout Road, New Lambton, NSW, 2305
Country 12915 0
Australia
Phone 12915 0
+61 2 49855568
Fax 12915 0
Email 12915 0
[email protected]
Contact person for scientific queries
Name 3843 0
Dr Stephen Smith
Address 3843 0
Department of Colorectall Surgery, Division of Surgery, John Hunter Hospital, Lookout Road, New Lambton, NSW, 2305
Country 3843 0
Australia
Phone 3843 0
+61 2 49855568
Fax 3843 0
Email 3843 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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