Back to resultsTraditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy
Primary Purpose
Seroma
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Low thermal electrosurgery system
Conventional Electrocautery
Sponsored by
About this trial
This is an interventional device feasibility trial for Seroma focused on measuring Mastectomy, Seroma
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Conventional electrocautery
Low thermal electrosurgery system
Arm Description
Outcomes
Primary Outcome Measures
Drainage volume after surgery
Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration
Secondary Outcome Measures
Post operative Pain
Post-operative Pain measured using 0-10 Numeric pain scale
Patient's Hospital costs
Expenses that the patient has to pay while staying in the hospital
Wound infection
Wound infection after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03167944
Brief Title
Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy
Official Title
"Comparison of Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy: A Prospective Randomized Controlled Trial"
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
March 25, 2018 (Anticipated)
Study Completion Date
October 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma
Keywords
Mastectomy, Seroma
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional electrocautery
Arm Type
Experimental
Arm Title
Low thermal electrosurgery system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Low thermal electrosurgery system
Intervention Description
PEAK Plasmablade
Intervention Type
Device
Intervention Name(s)
Conventional Electrocautery
Intervention Description
Conventional Electrocautery
Primary Outcome Measure Information:
Title
Drainage volume after surgery
Description
Drainage volume detected after surgery which is measured in drainage container and measured by syringe gauge aspiration
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Post operative Pain
Description
Post-operative Pain measured using 0-10 Numeric pain scale
Time Frame
Up to 24 weeks
Title
Patient's Hospital costs
Description
Expenses that the patient has to pay while staying in the hospital
Time Frame
up to 1 week
Title
Wound infection
Description
Wound infection after surgery
Time Frame
Up to 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piratthima Vachiraprakarnsakul
Phone
+66830693791
Email
piratthima.v@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suebwong Chuthapisith
Facility Information:
Facility Name
Faculty of Medicine, Siriraj Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piratthima Vachiraprakarnsakul
Phone
+66830693791
First Name & Middle Initial & Last Name & Degree
Piratthima Vachiraprakarnsakul, M.D.
12. IPD Sharing Statement
Learn more about this trial
Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy
We'll reach out to this number within 24 hrs