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

NCT03627442 | Unknown DMC

• 1 other identifier: 2017-8737
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• Flap perfusion viability

  This will be done by the plastic surgeon who will evaluate the flaps using PhotonVue images for flap perfusion of each breast flap after the mastectomy and before the immediate breast reconstruction. PhotonVue is an FDA approved fluorescence imaging system that is used as an adjuvant assessment tool of tissue perfusion, and blood circulation of free flaps used in plastic, micro- reconstruction, and organ transplant surgeries.16 PhotonVue images of the flap perfusion will be taken at 45-60 seconds post ICG injection. For each case, the plastic surgeons will report one of three outcomes: a) Left breast flap has a better viability, b) Right breast flap has a better viability, or c) both sides are similarly viable. After unbinding, the results will be reported according to the usage of PhotonBlade or Bovie cautery for each side.

  Immediately after mastectomy

• Change in Surgical Site Drainage

  This will be done by measuring surgical site drainage volume until removal of the drains for each breast.

  Post surgery until removal of drains from each breast, assessed up to 5 weeks

• Post-Operative Pain Assessment

  Pain Visual Analog Scale will be used to assess pain pre-operatively and post-operatively. Patient will be asked to report their pain score for each breast using the validated Pain Visual Analog Scale. The Visual Analog Scale For pain, asks the patient to draw a line indicating their level of pain on a 10 cm vertical line (where the bottom of the vertical line indicates no pain and the top indicates highest pain level). The line drawn by the patient will provide the pain score which will be calculated as the distance in mm from the bottom (no pain) level to the patient mark. As such, higher values will mean higher level of pain. Short term post pain will be reported as the mean of pain scores up to day 7, and longer term post op pain will be the pain score at day 30 post op. Up to 30 days post-op follow-up medical records will be used to collect incidences of post op surgical site complications.

  Change in pain for each breast will be assessed preoperatively and then postoperatively on days 1, 2, 3, 7 and 30.

• Surgical Site Complications

  Will document any surgical site complications.

  Day 1, 2 and 3 pot-surgery (until discharge) and up to 30 days.

• Surgical Site Drainage - Time

  This will be done by counting the days until removal of the drains for each breast

  Postsurgery and until removal of the drains

Study Arms (2)

Mastectomy with PhotonBlade

ACTIVE COMPARATOR

Patients undergoing double mastectomy with immediate reconstruction with expanders. One breast will be randomly selected to be operated with PhotonBlade

Procedure: Mastectomy with PhotonBlade

Mastectomy with Bovie

ACTIVE COMPARATOR

Patients undergoing double mastectomy with immediate reconstruction with expanders. One breast will be randomly selected to be operated with Bovie.

Procedure: Mastectomy with Bovie

Interventions

Mastectomy with PhotonBlade PROCEDURE

One of the breasts of each patient undergoing double mastectomy will be randomly assigned to breast flap creation with PhotonBlade

Mastectomy with PhotonBlade

Mastectomy with Bovie PROCEDURE

One of the breasts of each patient undergoing double mastectomy will be randomly assigned to breast flap creation with Bovie

Mastectomy with Bovie

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Invuity, Inc.: lead
• Montefiore Medical Center: collaborator

Related Publications (13)

• ACS. Breast Cancer Facts and Figures 2011-2012. (2012).

  BACKGROUND

• Girotto JA, Schreiber J, Nahabedian MY. Breast reconstruction in the elderly: preserving excellent quality of life. Ann Plast Surg. 2003 Jun;50(6):572-8. doi: 10.1097/01.SAP.0000069064.68579.19.

  PMID: 12783001 BACKGROUND

• Albornoz CR, Bach PB, Mehrara BJ, Disa JJ, Pusic AL, McCarthy CM, Cordeiro PG, Matros E. A paradigm shift in U.S. Breast reconstruction: increasing implant rates. Plast Reconstr Surg. 2013 Jan;131(1):15-23. doi: 10.1097/PRS.0b013e3182729cde.

  PMID: 23271515 BACKGROUND

• Gonzalez EG, Rancati AO. Skin-sparing mastectomy. Gland Surg. 2015 Dec;4(6):541-53. doi: 10.3978/j.issn.2227-684X.2015.04.21.

  PMID: 26645008 BACKGROUND

• Cho JW, Yoon ES, You HJ, Kim HS, Lee BI, Park SH. Nipple-Areola Complex Necrosis after Nipple-Sparing Mastectomy with Immediate Autologous Breast Reconstruction. Arch Plast Surg. 2015 Sep;42(5):601-7. doi: 10.5999/aps.2015.42.5.601. Epub 2015 Sep 15.

  PMID: 26430632 BACKGROUND

• Martinez CA, Reis SM, Sato EA, Boutros SG. The Nipple-Areola Preserving Mastectomy: A Multistage Procedure Aiming to Improve Reconstructive Outcomes following Mastectomy. Plast Reconstr Surg Glob Open. 2015 Oct 20;3(10):e538. doi: 10.1097/GOX.0000000000000516. eCollection 2015 Oct.

  PMID: 26579344 BACKGROUND

• van Verschuer VM, Maijers MC, van Deurzen CH, Koppert LB. Oncological safety of prophylactic breast surgery: skin-sparing and nipple-sparing versus total mastectomy. Gland Surg. 2015 Dec;4(6):467-75. doi: 10.3978/j.issn.2227-684X.2015.02.01.

  PMID: 26645001 BACKGROUND

• Tindholdt TT, Saidian S, Tonseth KA. Microcirculatory evaluation of deep inferior epigastric artery perforator flaps with laser Doppler perfusion imaging in breast reconstruction. J Plast Surg Hand Surg. 2011 Jun;45(3):143-7. doi: 10.3109/2000656X.2011.579721.

  PMID: 21682611 BACKGROUND

• Lin SJ, Nguyen MD, Chen C, Colakoglu S, Curtis MS, Tobias AM, Lee BT. Tissue oximetry monitoring in microsurgical breast reconstruction decreases flap loss and improves rate of flap salvage. Plast Reconstr Surg. 2011 Mar;127(3):1080-1085. doi: 10.1097/PRS.0b013e31820436cb.

  PMID: 21364410 BACKGROUND

• Garvey PB, Salavati S, Feng L, Butler CE. Perfusion-related complications are similar for DIEP and muscle-sparing free TRAM flaps harvested on medial or lateral deep inferior epigastric Artery branch perforators for breast reconstruction. Plast Reconstr Surg. 2011 Dec;128(6):581e-589e. doi: 10.1097/PRS.0b013e318230c122.

  PMID: 22094755 BACKGROUND

• Chirappapha P, Petit JY, Rietjens M, De Lorenzi F, Garusi C, Martella S, Barbieri B, Gottardi A, Andrea M, Giuseppe L, Hamza A, Lohsiriwat V. Nipple sparing mastectomy: does breast morphological factor related to necrotic complications? Plast Reconstr Surg Glob Open. 2014 Feb 7;2(1):e99. doi: 10.1097/GOX.0000000000000038. eCollection 2014 Jan.

  PMID: 25289296 BACKGROUND

• Patel KM, Hill LM, Gatti ME, Nahabedian MY. Management of massive mastectomy skin flap necrosis following autologous breast reconstruction. Ann Plast Surg. 2012 Aug;69(2):139-44. doi: 10.1097/SAP.0b013e3182250e23.

  PMID: 21734543 BACKGROUND

• Rusby JE, Smith BL, Gui GP. Nipple-sparing mastectomy. Br J Surg. 2010 Mar;97(3):305-16. doi: 10.1002/bjs.6970.

  PMID: 20101646 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Mohamad Sebai, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Sheldon Feldman, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennise D Dalma-Weiszhausz, PhD

CONTACT

6502486662; ddalma@invuity.com

John Kang

CONTACT

4158469105; jkang@invuity.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Initially, only breast surgeons knows which of the two devices was used for each breast, not plastic surgeon
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single blinded, randomized controlled pilot study (n=15) Only breast surgeon knows which device was used for each breast at initiation of surgery

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 13, 2018
• Study Start: August 15, 2018
• Primary Completion: August 15, 2019
• Study Completion: October 15, 2019
• Last Updated: August 13, 2018

Record last verified: 2018-07