Clinical trial NCT03711916: Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
Official title: Pilot Study: Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery for Mastectomy Breast Flap Creation With Immediate Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Mastectomy
Perfusion; Complications
Hemostasis
Keywords: Breast cancer
Mastectomy
Perfusion
Hemostasis
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2018-10-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perfusion
timeFrame: Day of Surgery
Secondary outcomes:
measure: Drainage
timeFrame: Up to 14 days post-operatively.
measure: Pain Scores
timeFrame: Days 1,2,3,7,30 Post-operatively
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Medicine Department of Surgery
name: Mehran Habibi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Medicine Department of Plastic, Reconstructive & Maxillofacial Surgery
name: Gedge D Rosson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habibi M, Prasath V, Dembinski R, Sacks JM, Rosson GD, Sebai ME, Mirkhaef S, Bello RJ, Siotos C, Broderick KP. Comparison of mastectomy and breast reconstruction outcomes using low thermal dissection versus traditional electrocautery: a blinded randomized trial. Breast Cancer Res Treat. 2021 Jul;188(1):101-106. doi: 10.1007/s10549-021-06177-9. Epub 2021 Mar 19.