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Completed Not applicable Interventional

Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery

ClinicalTrials.gov ID: NCT03711916

Public ClinicalTrials.gov record NCT03711916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 9:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Pilot Study: Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery for Mastectomy Breast Flap Creation With Immediate Breast Reconstruction

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Low thermal dissection devices have been introduced as a tool to improve surgical outcomes. PlasmaBlade, a low thermal dissection device, has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection device. Thus, low thermal devices would improve flap perfusion by decreasing the thermal injury resulted by the dissection. Looking into the use of low thermal devices in cases of mastectomy and immediate breast reconstruction has not been documented. The aim of this study is to determine if there are clinical flap perfusion, surgical site drainage, and pain scores differences between mastectomy flaps created using low thermal dissection device and those done with the standard care of Bovie cautery in order to warrant a formal study.

Study identification

NCT ID
NCT03711916
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
20 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 16, 2017
Primary completion
Oct 23, 2018
Completion
Dec 2, 2018
Last update posted
Jun 17, 2019

2017 – 2018

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Bayview Medical Center Baltimore Maryland 21224
Johns Hopkins Hospital Outpatient Center Baltimore Maryland 21287

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03711916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 17, 2019 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03711916 live on ClinicalTrials.gov.

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