Pilot Study: Post-operative Outcomes of Enhanced Energy Delivery Dissection for Mastectomy Breast Flap Creation With Immediate Breast Reconstruction
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- Post-Operative Pain Assessment
研究概览
简要总结
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
详细描述
Pilot Study: Post-Operative Outcomes of Enhanced Energy Delivery Dissection for Mastectomy Breast Flap Creation with Immediate Breast Reconstruction
Principal Investigator Sheldon M. Feldman, MD Chief, Division of Breast Surgery & Breast Surgical Oncology Director, Breast Cancer Services; Professor of Surgery Montefiore Medical Center- Albert Einstein College of Medicine New York, NY Email: sfeldman@montefiore.org
Co-Principal Investigator Mohamad E. Sebai, MD General Surgery Resident Montefiore Medical Center- Albert Einstein College of Medicine New York, NY Email: msebai@montefiore.org
Biostatistics: Michael Parides, PhD Professor Department of Surgery Montefiore Medical Center- Albert Einstein College of Medicine New York, NY Email: mparides@montefiore.org
Patricia Friedmann, MS Assistant Professor Department of Surgery Montefiore Medical Center- Albert Einstein College of Medicine New York, NY Email: patricia.friedmann@einstein.yu.edu
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Initially, only breast surgeons knows which of the two devices was used for each breast, not plastic surgeon
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Inflammatory breast cancer
- •Connective tissue disease
- •Previous breast radiotherapy
研究组 & 干预措施
Mastectomy with PhotonBlade
Patients undergoing double mastectomy with immediate reconstruction with expanders. One breast will be randomly selected to be operated with PhotonBlade
干预措施: Mastectomy with PhotonBlade (Procedure)
Mastectomy with Bovie
Patients undergoing double mastectomy with immediate reconstruction with expanders. One breast will be randomly selected to be operated with Bovie.
干预措施: Mastectomy with Bovie (Procedure)
结局指标
主要结局
Post-Operative Pain Assessment
时间窗: Change in pain for each breast will be assessed preoperatively and then postoperatively on days 1, 2, 3, 7 and 30.
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.
Flap perfusion viability
时间窗: Immediately after mastectomy
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.
Surgical Site Complications
时间窗: Day 1, 2 and 3 pot-surgery (until discharge) and up to 30 days.
Will document any surgical site complications.
Surgical Site Drainage - Time
时间窗: Postsurgery and until removal of the drains
This will be done by counting the days until removal of the drains for each breast
Change in Surgical Site Drainage
时间窗: Post surgery until removal of drains from each breast, assessed up to 5 weeks
This will be done by measuring surgical site drainage volume until removal of the drains for each breast.
次要结局
未报告次要终点