Breast Cancer Clinical Trial
Official title:
Pilot Study: Post-operative Outcomes of Enhanced Energy Delivery Dissection for Mastectomy Breast Flap Creation 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
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | October 15, 2019 |
Est. primary completion date | August 15, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Invuity, Inc. | Montefiore Medical Center |
ACS. Breast Cancer Facts and Figures 2011-2012. (2012).
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. — View Citation
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. — View Citation
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. — View Citation
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-9e. doi: 10.1097/PRS.0b013e318230c122. Erratum in: Plast Reconstr Surg. 2012 Jan;129(1):291. — View Citation
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. — View Citation
González EG, Rancati AO. Skin-sparing mastectomy. Gland Surg. 2015 Dec;4(6):541-53. doi: 10.3978/j.issn.2227-684X.2015.04.21. Review. — View Citation
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):1080-5. doi: 10.1097/PRS.0b013e31820436cb. — View Citation
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. — View Citation
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. — View Citation
Rusby JE, Smith BL, Gui GP. Nipple-sparing mastectomy. Br J Surg. 2010 Mar;97(3):305-16. doi: 10.1002/bjs.6970. Review. — View Citation
Tindholdt TT, Saidian S, Tønseth 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. — View Citation
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. Review. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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. | |
Primary | Surgical Site Complications | Will document any surgical site complications. | Day 1, 2 and 3 pot-surgery (until discharge) and up to 30 days. | |
Primary | 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 |
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