Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy

NCT ID: NCT03167944

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2018-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Seroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional electrocautery

Group Type EXPERIMENTAL

Conventional Electrocautery

Intervention Type DEVICE

Conventional Electrocautery

Low thermal electrosurgery system

Group Type EXPERIMENTAL

Low thermal electrosurgery system

Intervention Type DEVICE

PEAK Plasmablade

Interventions

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Low thermal electrosurgery system

PEAK Plasmablade

Intervention Type DEVICE

Conventional Electrocautery

Conventional Electrocautery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female aged \>18 years old
* Patients that fulfill the indication of mastectomy
* Medium-sized breast volume (Breast weight \< 1500 grams)

Exclusion Criteria

* Patients who cannot complete the informed consent
* Patients with ASA CLASS \> 3
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Suebwong Chuthapisth

Asst. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Piratthima Vachiraprakarnsakul

Role: CONTACT

+66830693791

Suebwong Chuthapisith

Role: CONTACT

Facility Contacts

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Piratthima Vachiraprakarnsakul

Role: primary

+66830693791

Other Identifiers

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convplas

Identifier Type: -

Identifier Source: org_study_id

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