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Trial registered on ANZCTR
Registration number
ACTRN12623000322639p
Ethics application status
Submitted, not yet approved
Date submitted
1/02/2023
Date registered
27/03/2023
Date last updated
27/03/2023
Date data sharing statement initially provided
27/03/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of diathermy setting on post-operative seroma following abdominoplasty
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Scientific title
The effect of diathermy setting on post-operative seroma following abdominoplasty
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Secondary ID [1]
308883
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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:
Seroma following abdominoplasty
328877
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Condition category
Condition code
Surgery
325870
325870
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients included will be those consenting patients who are undergoing abdominoplasty, with the intervention/technique compared being the diathermy setting used during the operation. For excision of tissue and dissection of abdominoplasty flaps, a monopolar coagulation diathermy with power setting of 20W will be used for one group, whilst a monopolar coagulation diathermy with power setting of 35W will be used in the second group, and a monopolar cutting diathermy with power setting of 35W will be used for the third group
Diathermy will be used throughout the dissection portion of the abdominoplasty (excising out skin and raising abdominal flaps).
This is estimated to be the first 30 minutes of the operation.
The same 2 surgeons will operate with all three diathermy settings.
All other aspects of the abdominoplasty will proceed as per usual practice.
The control will be monopolar coagulation diathermy with power setting of 35W .
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Intervention code [1]
325330
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Treatment: Surgery
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Comparator / control treatment
The three groups in the previous questions are all standard techniques, and will be compared against each other. The control will be monopolar coagulation diathermy with power setting of 35W.
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Control group
Active
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Outcomes
Primary outcome [1]
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Clinical seroma formation, which will be diagnosed clinically by treating surgeon and recorded in the hospital/clinic records, volume will then be estimated with ultrasound and measured when drained.
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Assessment method [1]
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Timepoint [1]
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6 weeks post operative
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Secondary outcome [1]
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Length of surgery, which will be recorded from time of knife to skin, to completion of suture closure of the wound. Data will be collected in the study data collection sheet
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Assessment method [1]
417991
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Timepoint [1]
417991
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6 weeks post operative
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Secondary outcome [2]
417992
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Length of stay in hospital, which will be measured in days, and data will be collected in the study data collection sheet
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Assessment method [2]
417992
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Timepoint [2]
417992
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6 weeks post operative
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Secondary outcome [3]
417993
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Daily drain output, which will be measured in ml, and collected by ward nursing staff and recorded in the medical record
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Assessment method [3]
417993
0
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Timepoint [3]
417993
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6 weeks post operative
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Secondary outcome [4]
417994
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Day of drain removal, which will be measured in days, and data will be collected in the study data collection sheet
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Assessment method [4]
417994
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Timepoint [4]
417994
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6 weeks post operative
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Secondary outcome [5]
417995
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Complications will be diagnosed by the treating surgeon, and measured where applicable with appropriate examination or investigations (e.g. ultrasound). This will be added to the hospital/clinic medical records as well as the data collection sheet.
Examples of potential complications include seroma, haematoma and infection
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Assessment method [5]
417995
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Timepoint [5]
417995
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6 weeks post operative
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Eligibility
Key inclusion criteria
All adult patients presenting to the Surgeons involved who are undergoing abdominoplasty and provide informed consent to partake
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Minimum age
18
Years
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Maximum age
No limit
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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
Those who do not consent to participate.
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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
30/03/2023
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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
195
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Dr Amira Sanki
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Address [1]
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Southern Aesthetic Plastic Surgery
507/15 Kensington St, Kogarah NSW 2217
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Country [1]
313098
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Australia
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Primary sponsor type
Individual
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Name
Dr Amira Sanki
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Address
Southern Aesthetic Plastic Surgery
507/15 Kensington St, Kogarah NSW 2217
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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]
314793
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Address [1]
314793
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Country [1]
314793
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Ramsay National Research Unit, HREC A
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Ethics committee address [1]
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Level 7, Tower B, 7 Westbourne St, St Leonards NSW 2065
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Ethics committee country [1]
312344
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Australia
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Date submitted for ethics approval [1]
312344
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16/01/2023
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Approval date [1]
312344
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Ethics approval number [1]
312344
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Summary
Brief summary
Abdominoplasty is one of the most common plastic surgery procedures performed in Australia. A common complication of abdominoplasty is the formation of post operative seroma, which is thought to be influenced by dissection technique utilised by the surgeon.
We propose to conduct a study of patients undergoing abdominoplasty, comparing seroma rates with three different diathermy settings. The proposal will be a prospective, randomised, study of consecutive patients undergoing abdominoplasty, with no exclusion criteria. Only patients consenting to involvement will be included. For excision of tissue and dissection of flaps, a monopolar coagulation diathermy with power setting of 20W will be used for one group, a monopolar coagulation diathermy with power setting of 35W will be used in the second group, and a monopolar cutting diathermy with power setting of 35W will be used for the third group. All three diathermy settings are well within usual range of setting used for diathermy and pose negligible additional risk to patients in either group. We hypothesize that the lower diathermy and cutting settings will result in lower seroma rates, due to less soft tissue damage during dissection. The general surgical technique involves scalpel skin incision, monopolar dissection, liposuction, rectus divarification repair where indicated, and layered soft tissue closure. Compression garment’s will be placed at the conclusion of surgery and continued fulltime for 6 weeks.
Patient demographic factors and surgical technique baseline characteristics will be compared. Drains will be emptied at midnight daily by ward nurses who are blinded to the study, with outputs documented at 24-hour intervals. Postoperative mobilisation commences on day 1, with a physiotherapist. Drains will be removed when they were <30ml/d for 2 consecutive days.
Data collected will include: baseline demographics, surgical technique, daily drain outputs, time to removal of drains, development of postoperative complications. If complications include seroma or haematoma, the size, location and subsequent management will be noted. Follow up period for the purpose of this study will be 6 weeks post operatively.
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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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Dr Amira Sanki
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Address
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Southern Aesthetic Plastic Surgery
507/15 Kensington St, Kogarah NSW 2217
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Country
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Australia
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Phone
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+61 2 9588 2494
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Y. Gehan Karunaratne
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Address
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Royal Prince Alfred Hospital
50 Missenden Road
Camperdown, 2050
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Country
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Australia
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Phone
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+61432023263
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Fax
124327
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Y. Gehan Karunaratne
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Address
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Royal Prince Alfred Hospital
50 Missenden Road
Camperdown, 2050
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Country
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Australia
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Phone
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+61 432023263
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18199
Study protocol
[email protected]
18200
Informed consent form
[email protected]
18201
Ethical approval
[email protected]
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.
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