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

Johns Hopkins Medicine

Status: Completed

Conditions: Hemostasis; Breast Cancer; Mastectomy; Perfusion; Complications

Treatments: Device: PlasmaBlade 3.0S

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03711916

IRB00108493 (Other Identifier)

J1697

Details and patient eligibility

About

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.

Full description

This is a single-blinded, randomized, controlled clinical trial comparing postoperative flap perfusion and surgical site drainage between patients randomized to breast flap creation by PlasmaBlade (low thermal dissection intervention) on one breast and by a Bovie cautery (Control) for the contralateral breast flap. Candidates will have elected to undergo bilateral post-mastectomy immediate breast reconstruction (IBR). Participants meeting inclusion criteria will be enrolled and baseline data collection completed prior to randomization and surgery.

Patients and the plastic surgeon will be blinded in regards to intervention randomization. Only the oncology surgeon has knowledge of which device used for each breast flap. However, after the plastic surgeon makes the assessment of the flap, he/she will be unblinded in order to complete the reconstruction procedure using the same dissection device on the same side it was used for in the mastectomy procedure. Patient-specific surgical details will be recorded intraoperatively. Following the surgery, post-operative flap perfusion will be recorded using SPY imaging system. Surgical site drainage will be measured until drainage removal. Post-operative pain (Visual Analog Scale for Pain) and the occurrence of adverse events will be recorded up until discharge and 30-days postoperative follow up visit.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Active connective tissue disease.
• History of, or plan to undergo irradiation of the breasts.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Breast flap creation with PlasmaBlade

Experimental group

Description:

During participant's scheduled bilateral mastectomy, breast flap on one breast will be created using low thermal dissection device (PlasmaBlade) on one breast and standard Bovie cautery in the contralateral breast.

Treatment:

Device: PlasmaBlade 3.0S

Breast flap creation with Bovie Cautery

No Intervention group

Description:

During participant's scheduled bilateral mastectomy, breast flap will be created using standard Bovie cautery on the breast contralateral to the one that was created using PlasmaBlade.