Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
The effect of diathermy setting on post-operative seroma following abdominoplasty
Secondary ID [1] 308883 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seroma following abdominoplasty 328877 0
Condition category
Condition code
Surgery 325870 325870 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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 .
Intervention code [1] 325330 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 333706 0
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.
Timepoint [1] 333706 0
6 weeks post operative
Secondary outcome [1] 417991 0
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
Timepoint [1] 417991 0
6 weeks post operative
Secondary outcome [2] 417992 0
Length of stay in hospital, which will be measured in days, and data will be collected in the study data collection sheet
Timepoint [2] 417992 0
6 weeks post operative
Secondary outcome [3] 417993 0
Daily drain output, which will be measured in ml, and collected by ward nursing staff and recorded in the medical record
Timepoint [3] 417993 0
6 weeks post operative
Secondary outcome [4] 417994 0
Day of drain removal, which will be measured in days, and data will be collected in the study data collection sheet
Timepoint [4] 417994 0
6 weeks post operative
Secondary outcome [5] 417995 0
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
Timepoint [5] 417995 0
6 weeks post operative

Eligibility
Key inclusion criteria
All adult patients presenting to the Surgeons involved who are undergoing abdominoplasty and provide informed consent to partake
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who do not consent to participate.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
195
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313098 0
Self funded/Unfunded
Name [1] 313098 0
Dr Amira Sanki
Country [1] 313098 0
Australia
Primary sponsor type
Individual
Name
Dr Amira Sanki
Address
Southern Aesthetic Plastic Surgery
507/15 Kensington St, Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 314793 0
None
Name [1] 314793 0
Address [1] 314793 0
Country [1] 314793 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312344 0
Ramsay National Research Unit, HREC A
Ethics committee address [1] 312344 0
Level 7, Tower B, 7 Westbourne St, St Leonards NSW 2065
Ethics committee country [1] 312344 0
Australia
Date submitted for ethics approval [1] 312344 0
16/01/2023
Approval date [1] 312344 0
Ethics approval number [1] 312344 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124326 0
Dr Amira Sanki
Address 124326 0
Southern Aesthetic Plastic Surgery
507/15 Kensington St, Kogarah NSW 2217
Country 124326 0
Australia
Phone 124326 0
+61 2 9588 2494
Fax 124326 0
Email 124326 0
amira@southernaesthetic.com.au
Contact person for public queries
Name 124327 0
Dr Y. Gehan Karunaratne
Address 124327 0
Royal Prince Alfred Hospital
50 Missenden Road
Camperdown, 2050
Country 124327 0
Australia
Phone 124327 0
+61432023263
Fax 124327 0
Email 124327 0
gehan_k@hotmail.com
Contact person for scientific queries
Name 124328 0
Dr Y. Gehan Karunaratne
Address 124328 0
Royal Prince Alfred Hospital
50 Missenden Road
Camperdown, 2050
Country 124328 0
Australia
Phone 124328 0
+61 432023263
Fax 124328 0
Email 124328 0
gehan_k@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18199Study protocol  gehan_k@hotmail.com
18200Informed consent form  gehan_k@hotmail.com
18201Ethical approval  gehan_k@hotmail.com



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.