SeromaNCT03167944
Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy
A study testing Low thermal electrosurgery system and Conventional Electrocautery in people with Seroma, run by Mahidol University at 1 site in Thailand.
Trial summary
Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Seroma
- What is being tested?
- Low thermal electrosurgery system and Conventional Electrocautery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 15 Mar 2017to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female aged >18 years old
- Patients that fulfill the indication of mastectomy
- Medium-sized breast volume (Breast weight < 1500 grams)
Who cannot join
- Patients who cannot complete the informed consent
- Patients with ASA CLASS > 3
Trial locations and contacts
1 site in 1 country.
Suebwong Chuthapisith contact
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Siriraj Hospital
Bangkok
Piratthima Vachiraprakarnsakul, +66830693791
Piratthima Vachiraprakarnsakul, M.D.
About this study
Official title: "Comparison of Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy: A Prospective Randomized Controlled Trial"
Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.
- Conditions
- Seroma
- Being tested
- Low thermal electrosurgery system, Conventional Electrocautery
- Keywords
- Mastectomy, Seroma
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low thermal electrosurgery systemDevice
PEAK Plasmablade
Conventional ElectrocauteryDevice
Conventional Electrocautery
| Study group | Role | What they receive |
|---|---|---|
| Conventional electrocautery | Experimental | Not described Receives: Device: Conventional Electrocautery |
| Low thermal electrosurgery system | Experimental | Not described Receives: Device: Low thermal electrosurgery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drainage volume after surgery
Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration
Measured: Up to 24 weeks
Secondary outcomes (3)
Post operative Pain
Post-operative Pain measured using 0-10 Numeric pain scale
Measured: Up to 24 weeks
Patient's Hospital costs
Expenses that the patient has to pay while staying in the hospital
Measured: up to 1 week
Wound infection
Wound infection after surgery
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start15 Mar 2017
- Primary completion25 Mar 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suebwong Chuthapisth, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167944
- Sponsor's protocol ID
- convplas
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy: A Prospective Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT03167944
- Acronym / sponsor ID
- convplas
- Conditions
- Seroma
- Keywords
- Mastectomy, Seroma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 25 Mar 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional electrocautery | Experimental | Device: Conventional Electrocautery |
| Low thermal electrosurgery system | Experimental | Device: Low thermal electrosurgery system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female aged >18 years old
- Patients that fulfill the indication of mastectomy
- Medium-sized breast volume (Breast weight < 1500 grams)
Key exclusion criteria (2 listed)
- Patients who cannot complete the informed consent
- Patients with ASA CLASS > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low thermal electrosurgery systemPEAK Plasmablade | Device | Low thermal electrosurgery system |
| Conventional ElectrocauteryConventional Electrocautery | Device | Conventional electrocautery |
Primary outcome
Drainage volume after surgery
Time frame: Up to 24 weeks
Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration
3 secondary outcomes
Post operative Pain
Time frame: Up to 24 weeks
Patient's Hospital costs
Time frame: up to 1 week
Wound infection
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suebwong Chuthapisith contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low thermal electrosurgery system and Conventional Electrocautery in people with Seroma, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piratthima Vachiraprakarnsakul (+66830693791, piratthima.v@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drainage volume after surgery (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017; AzTrials last refreshed its copy on 30 Oct 2026.