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

NCT03711916 | Completed FDA Device

• 2 other identifiers: J1697IRB00108493
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Mastectomy; Perfusion; Complications; Hemostasis

Keywords

Breast cancer; Mastectomy; Perfusion; Hemostasis

Outcome Measures

Primary Outcomes (1)

• Perfusion

  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.

  Day of Surgery

Secondary Outcomes (2)

• Drainage

  Up to 14 days post-operatively.

• Pain Scores

  Days 1,2,3,7,30 Post-operatively

Study Arms (2)

Breast flap creation with PlasmaBlade

EXPERIMENTAL

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

Breast flap creation with Bovie Cautery

NO INTERVENTION

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.

Interventions

PlasmaBlade 3.0S DEVICE

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.

Breast flap creation with PlasmaBlade

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Only enrolling women undergoing bilateral mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Medtronic: collaborator

Study Sites (2)

Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 33742323 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mehran Habibi, MD

  Johns Hopkins Medicine Department of Surgery

  PRINCIPAL INVESTIGATOR

• Gedge D Rosson, MD

  Johns Hopkins Medicine Department of Plastic, Reconstructive & Maxillofacial Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: March 17, 2017
• Primary Completion: October 24, 2018
• Study Completion: December 3, 2018
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)