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ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery

NCT03166384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-09-08

No results posted yet for this study

Summary

There was no study about application of electrosurgical bipolar sealing device for mastectomy in Korean population, because Korean national insurance did not cover use of the advanced sealing device until last year. Sample size of the previous studies was too small to draw a solid conclusion. Therefore, this study was designed prospectively to evaluate whether application of bipolar energy device for mastectomy could provide clinical benefit in terms of reducing seroma formation.

Conditions

  • Seroma as Procedural Complication

Interventions

DEVICE

electrosurgical bipolar sealing devices

Electrosurgical bipolar sealing devices use the body's own collagen and elastin to create a permanent fusion zone through a combination of pressure and energy. Previous studies suggested that surgery using these devices lead to significant decrease of seroma formation, however their advantages are not well established in case of mastectomy for breast cancer.

PROCEDURE

conventional suture and tie

the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible.

Sponsors & Collaborators

  • Severance Hospital

    lead OTHER

Principal Investigators

  • Hyung Seok Park, MD · Yonsei University College of Medicine, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-03-01
Completion
2022-06-27
FDA Device
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03166384 on ClinicalTrials.gov