Trial Review

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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.
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.
Secondary ID [1] 259645 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cosmetic outcome of skin incisions 261211 0
Hernia repair 261254 0
Midline laparotomy 261255 0
Condition category
Condition code
Surgery 259362 259362 0 0
Surgical techniques
Oral and Gastrointestinal 259409 259409 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 258077 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 262174 0
Patient based cosmetic outcome choosing which side has the better cosmetic outcome.
Timepoint [1] 262174 0
1 month and 6 months.
Primary outcome [2] 262175 0
Independant assessor choosing which side has the better cosmetic outcome.
Timepoint [2] 262175 0
1 month and 6 months.
Secondary outcome [1] 273270 0
Nil
Timepoint [1] 273270 0
Nil

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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to consent for study.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3649 0
3220
Recruitment postcode(s) [2] 3650 0
3216
Recruitment postcode(s) [3] 3651 0
3218
Recruitment postcode(s) [4] 3652 0
3214
Recruitment postcode(s) [5] 3653 0
3215

Funding & Sponsors
Funding source category [1] 258539 0
Hospital
Name [1] 258539 0
Barwon Health
Country [1] 258539 0
Australia
Funding source category [2] 258564 0
Hospital
Name [2] 258564 0
Department of Surgery - Geelong Hospital
Country [2] 258564 0
Australia
Primary sponsor type
Hospital
Name
Geelong Hospital
Address
Ryrie St
Geelong 3220
VIC
Country
Australia
Secondary sponsor category [1] 257675 0
None
Name [1] 257675 0
Address [1] 257675 0
Country [1] 257675 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260543 0
Ethics committee address [1] 260543 0
Ethics committee country [1] 260543 0
Date submitted for ethics approval [1] 260543 0
02/03/2011
Approval date [1] 260543 0
Ethics approval number [1] 260543 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32247 0
Address 32247 0
Country 32247 0
Phone 32247 0
Fax 32247 0
Email 32247 0
Contact person for public queries
Name 15494 0
Felix Sim
Address 15494 0
Geelong Hospital
Ryrie St
Geelong
VIC 3220
Country 15494 0
Australia
Phone 15494 0
+61 3 5226 7111
Fax 15494 0
Email 15494 0
[email protected]
Contact person for scientific queries
Name 6422 0
Felix Sim
Address 6422 0
Geelong Hospital
Ryrie St
Geelong
VIC 3220
Country 6422 0
Australia
Phone 6422 0
+61 3 5226 7111
Fax 6422 0
Email 6422 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23189Other   
23800Other    Link to published article

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.