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

• ClinicalTrials.gov Identifier: NCT03711916
• Recruitment Status: Completed
• First Posted: October 19, 2018
• Last Update Posted: June 18, 2019
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Medtronic
• Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Mastectomy; Perfusion; Complications; Hemostasis	Device: PlasmaBlade 3.0S	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Device Feasibility
• Official Title: Pilot Study: Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery for Mastectomy Breast Flap Creation With Immediate Breast Reconstruction
• Actual Study Start Date: March 17, 2017
• Actual Primary Completion Date: October 24, 2018
• Actual Study Completion Date: December 3, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Breast flap creation with PlasmaBlade; 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.	Device: PlasmaBlade 3.0S; PlasmaBlade (Medtronic) is approved by United States Food and Drug Administration (FDA) as a low thermal dissection device that has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection devices.
No Intervention: Breast flap creation with Bovie Cautery; 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.

Outcome Measures

Primary Outcome Measures :

1. Perfusion [ Time Frame: Day of Surgery ]
   Plastic surgeon objectively assesses degree of perfusion with the SPY Perfusion Assessment system (intra-operative fluorescence imaging system). Plastic surgeon describes perfusion as Left better than Right, Right better than Left, or both sides equally perfused.

Secondary Outcome Measures :

1. Drainage [ Time Frame: Up to 14 days post-operatively. ]
   Patient records amount of drainage (in cc's) from each drain until drain is removed by plastic surgeon.
2. Pain Scores [ Time Frame: Days 1,2,3,7,30 Post-operatively ]
   Patient records pains scores using Visual Analog Scale (10cm long line upon which patients indicates level of pain)for each side at Day 1, 2, 3, 7, and 30. Scores range from 0-10. Score of 0 corresponds with 0 cm on the line and 10 corresponds with 10cm on the line. 0 indicates no pain and 10 indicates most severe pain.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only enrolling women undergoing bilateral mastectomy
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Maryland

Bayview Medical Center

Baltimore, Maryland, United States, 21224

Johns Hopkins Hospital Outpatient Center

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Medtronic

Investigators

• Principal Investigator: Mehran Habibi, MD; Johns Hopkins Medicine Department of Surgery
• Principal Investigator: Gedge D Rosson, MD; Johns Hopkins Medicine Department of Plastic, Reconstructive & Maxillofacial Surgery

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT03711916
• Other Study ID Numbers: J1697; IRB00108493 ( Other Identifier: JHM IRB )
• First Posted: October 19, 2018
• Last Update Posted: June 18, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:

Breast cancer; Mastectomy; Perfusion; Hemostasis

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases