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Trial registered on ANZCTR
Registration number
ACTRN12611000222943
Ethics application status
Not yet submitted
Date submitted
25/02/2011
Date registered
1/03/2011
Date last updated
1/03/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparison of cosmetic outcomes of diathermy versus scalpel for skin incisions.
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Scientific title
In patients undergoing elective open hernia repair and midline laparotomy surgery, is the use of diathermy for skin incisions comparable to scalpel for patient based cosmetic outcome of wound healing.
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Secondary ID [1]
259645
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cosmetic outcome of skin incisions
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Hernia repair
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Midline laparotomy
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Condition category
Condition code
Surgery
259362
259362
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0
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Surgical techniques
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Oral and Gastrointestinal
259409
259409
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Skin incisions with monopolar diathermy. Estimated duration for incising skin with diathermy(intervention) should take no longer than 30 seconds. The remaining time of the operation will depend on the nature and complexity of procedure and this does not relate to the intervention but more to the underlying pathology or disease being treated with the proposed surgery.
One half of the wound will be incised using a monopolar diathermy on "Cutting" setting. The depth of incision will be limited to the full depth of dermis only, just like with the scalpel incision.
Dissection of the subcutaneous tissue will be done in the conventional method using diathermy on "Coagulation" setting.
All patients will have incisions done with a diathermy and scalpel. Randomisation process will determine which half of the skin wound is incised with diathermy and which half with scalpel.
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Intervention code [1]
258077
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Treatment: Surgery
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Comparator / control treatment
Skin incisions with scalpel blade. The skin incision with scalpel blade will be performed in the standard conventional fashion incising to the full depth of dermis.
Dissection of the subcutaneous tissue will be done in the conventional method using diathermy on "Coagulation" setting.
All patients will have incisions done with a diathermy and scalpel. Randomisation process will determine which half of the skin wound is incised with diathermy and which half with scalpel.
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Control group
Active
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Outcomes
Primary outcome [1]
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Patient based cosmetic outcome choosing which side has the better cosmetic outcome.
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Assessment method [1]
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Timepoint [1]
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1 month and 6 months.
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Primary outcome [2]
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Independant assessor choosing which side has the better cosmetic outcome.
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Assessment method [2]
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Timepoint [2]
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1 month and 6 months.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
273270
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Nil
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Eligibility
Key inclusion criteria
1) Patients undergoing surgery for open hernia repair or midline laparotomy surgery.
2) Able to comprehend and sign consent form and verbal questionaire.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Inability to consent for study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As participants will act as their own control(cross-over trial), recruitment of subjects will be from those patients on the waiting list undergoing elective hernia repair or those undergoing midline laparotomy surgery. Allocation will be done by the principal researcher (Felix Sim) and placed in a sealed opaque envelope. Each envelope will be numbered and these numbers will be allocated to each patient. Information containing which half of the wound is diathermy/scalpel will be known by the operating surgeon and principal researcher and therefore is not completely concealed.
After consent is obtained, theatre staff will handover a sealed opaque envelope to the operating surgeon outlining which half of the wound will be incised with diathermy and which half with scalpel blade.
Apart from the different method of skin incision, the rest of surgery will be carried out in the usual fashion as per the operating surgeon.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each patient will have half of their incision done with a scalpel blade and dathermy. Randomisation into one of the two groups will be done using a coin toss to determine which instrument is used to incise the lateral half or superior half of the wound. Heads will represent diathermy and tails will represent scalpel. The participants will be blinded to this randomisation process. Both participants and assessors will be blinded to this randomisation process.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
3649
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3220
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Recruitment postcode(s) [2]
3650
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3216
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Recruitment postcode(s) [3]
3651
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3218
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Recruitment postcode(s) [4]
3652
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3214
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Recruitment postcode(s) [5]
3653
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3215
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Barwon Health
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Address [1]
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Geelong Hospital
Ryrie St
Geelong 3220
VIC
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Country [1]
258539
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Australia
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Funding source category [2]
258564
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Hospital
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Name [2]
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Department of Surgery - Geelong Hospital
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Address [2]
258564
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Ryrie St
Geelong 3220
VIC
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Country [2]
258564
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Australia
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Primary sponsor type
Hospital
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Name
Geelong Hospital
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Address
Ryrie St
Geelong 3220
VIC
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
257675
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Country [1]
257675
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
260543
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Ethics committee address [1]
260543
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Ethics committee country [1]
260543
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Date submitted for ethics approval [1]
260543
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02/03/2011
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Approval date [1]
260543
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Ethics approval number [1]
260543
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Summary
Brief summary
This study aims to compare the cosmetic outcomes of skin incisions made by diathermy and scalpel blade. Patients undergoing open hernia repair or elective midline laparotomy surgery will be recruited for this study. Each half of the incision (medial/lateral or superior/inferior) will be randomised into scalpel(control) or diathermy(intervention). Patients are blinded to this randomisation process. Primary outcome is the patient’s and independent observer’s assessment of which half of the wound has the better cosmetic outcome.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
32247
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Phone
32247
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Fax
32247
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Email
32247
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Contact person for public queries
Name
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Felix Sim
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Address
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Geelong Hospital
Ryrie St
Geelong
VIC 3220
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Country
15494
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Australia
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Phone
15494
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+61 3 5226 7111
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Fax
15494
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Email
15494
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[email protected]
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Contact person for scientific queries
Name
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Felix Sim
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Address
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Geelong Hospital
Ryrie St
Geelong
VIC 3220
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Country
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Australia
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Phone
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+61 3 5226 7111
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23189
Other
23800
Other
Link to published article
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4961
Plain language summary
Yes
https://doi.org/10.1111/ans.12434
Stupart DA, Sim FW, Chan ZH, Guest GD, Watters DA....
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More Details
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Documents added automatically
No additional documents have been identified.
Download to PDF