NCT03167944

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 23, 2017

Last Update Submit

May 24, 2017

Conditions

Seroma

Keywords

MastectomySeroma

Outcome Measures

Primary Outcomes (1)

  • Drainage volume after surgery

    Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration

    Up to 24 weeks

Secondary Outcomes (3)

  • Post operative Pain

    Up to 24 weeks

  • Patient's Hospital costs

    up to 1 week

  • Wound infection

    Up to 24 weeks

Study Arms (2)

Conventional electrocautery

EXPERIMENTAL
Device: Conventional Electrocautery

Low thermal electrosurgery system

EXPERIMENTAL
Device: Low thermal electrosurgery system

Interventions

Low thermal electrosurgery systemDEVICE

PEAK Plasmablade

Low thermal electrosurgery system
Conventional ElectrocauteryDEVICE

Conventional Electrocautery

Conventional electrocautery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who cannot complete the informed consent
  • Patients with ASA CLASS \> 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Siriraj Hospital

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Piratthima Vachiraprakarnsakul

CONTACT

+66830693791piratthima.v@gmail.com

Suebwong Chuthapisith

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Professor

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 30, 2017

Study Start

March 15, 2017

Primary Completion

March 25, 2018

Study Completion

October 30, 2018

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

TH(1)