Post-op Outcomes of Enhanced Energy Delivery Dissection for Mastectomy With Immediate Breast Reconstruction

Principal Investigator: Sheldon Feldman, MD Co-Principal Investigator: Mohamad Sebai, MD Department of Surgery, Montefiore Medical Center - Einstein College of Medicine Title Pilot Study: Post-operative outcomes of enhanced energy delivery dissection for mastectomy breast flap creation with immediate breast reconstruction Goal Determine the feasibility of a study design that includes the evaluation of breast flap viability, postoperative surgical site drainage, post-operative pain/surgical site complications, time to complete mastectomy with Photonblade (PB) vs traditional electrosurgery devices. Overall outcome If determined feasible, consider going to clinical trial. Timing 6 months starting after execution of contract Study population Women between 18-65 years old Choose bilateral mastectomy followed by immediate breast reconstruction (through tissue expander insertion) No inflammatory breast cancer/no radiotherapy Study design Single blinded, randomized controlled pilot study (n=15) Only breast surgeon knows which device was used for each breast Study feasibility endpoints Flap Viability - compare perfusion, using PhotonVue, of flaps creation using PB vs Bovie (left is better, right is better or they are similar) Site drainage - Measure drainage volume and duration Pain scores and complications - Subjective pain assessment on days 1, 2, 3, 7 and 30 post-op. (Pain visual Analog Scale). Surgical site complications will be recorded up to 30-days post-op. Time to completion of mastectomy flap using PB vs Bovie will be recorded. (Time in minutes between initial incision and completion of mastectomy for each side) Analysis Descriptive analysis will be performed to examine data distribution, missing data and data errors. Continuous variables will be summarized using means or medians; categorical variables will be summarized using proportions. CLINICAL TRIAL Objectives Determine if post-op flap viability differs between women getting mastectomy flap creation using PB vs Bovie Determine if post-op site drainage measures differs between two devices Determine if post-op pain measures differ when using PB vs Bovie Determine if time to mastectomy flap creation differs between using Bovie and PB

Sex

Female

Minimum age

18 Years

Maximum age

65 Years

Inclusion Criteria:

* Patients with or without breast cancer whom are candidates for and choose bilateral mastectomy followed by immediate breast reconstruction (tissue expander based breast reconstruction).
* Patients who had neoadjuvant chemotherapy are not excluded from participation
* Understand the study purpose, requirements, and risks.
* Be able and willing to give informed consent.

Exclusion Criteria:

* Inflammatory breast cancer
* Connective tissue disease
* Previous breast radiotherapy

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