Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
Completed · Not applicable
Conditions studied: Breast Cancer, Mastectomy, Perfusion; Complications, Hemostasis
In brief
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.
Key facts
- Study ID
- NCT03711916
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 20
- Starts
- 2017-03-17
- Expected to finish
- 2018-12-03
- Last updated by the study team
- 2019-06-18
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women aged 18-75 years.
- Choose bilateral mastectomy followed by immediate breast reconstruction.
- Have no inflammatory breast cancers.
- Have not had radiotherapy before mastectomy.
- Understand the study purpose, requirements, and risks.
- Be able and willing to give informed consent.
You may not qualify if…
- Active connective tissue disease.
- History of, or plan to undergo irradiation of the breasts.
Where it is running
- Bayview Medical Center — Baltimore, Maryland, United States
- Johns Hopkins Hospital Outpatient Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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