The BREAST Trial: A Randomized, Non-inferiority, Study Comparing the Complication Profile of Four Commercially Available Acellular Dermal Matrixes Used in Alloplastic Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 328
- 试验地点
- 8
- 主要终点
- Seroma incidence
研究概览
简要总结
This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.
详细描述
This study is a randomized control trial and will include all patients who are agreeable and deemed appropriate for alloplastic breast reconstruction involving the use of an ADM with two stage tissue expander (TE) reconstruction. The ADMs used will be determined by random assignment to one of four available products being utilized within the study: AlloDerm, AlloMax, DermACELL and FlexHD. Each ADM product will comprise of an individual treatment arm. Participants undergoing bilateral reconstruction will have the same ADM used in each side. The four treatment arms will be compared to assess their impact on our primary outcome: proportion of clinically significant post-operative seroma requiring intervention. Analysis will be performed per surgeon to prevent post-operative outcomes from being confounded by the principle operator. The trial will initially be conducted as an internal pilot study. The study will initially target a study population of 40 patients for recruitment as a means to assess the feasibility of the study. In doing this, the pilot study will be able to establish the necessary protocol and administrative infrastructure that is needed to complete the trial in its entirety. This create a sample population for initial outcomes.
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
- Single (Participant)
盲法说明
Treatment information will be non-blinded to the surgical staff who will then proceed to order the appropriate ADM product to be available at the time of the study participants scheduled breast reconstruction. Additionally, randomization will occur independently for each surgeon prevent bias from arising as a result of the surgeon performing the reconstruction.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM.
- •Breast reconstruction must be done by means of a two staged process using tissue expanders and ADM based reconstruction followed by implant tissue expander to implant exchange.
排除标准
- •Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion.
- •Patients with a history of previous breast reconstruction procedures.
- •Patients with prior radiation treatment to the breast or with prior mantle radiation
- •Any patient with a contraindication to breast reconstruction
- •Patients undergoing an axillary node dissection with clearance
- •Patients with an allergy to Polysporin or any of its ingredients.
- •Patients with contraindications to any of the acellular dermal matrices:
- •DermACELL: Allergy to Gentamicin, Vancomycin[12]
- •The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively, there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure.
结局指标
主要结局
Seroma incidence
时间窗: Within 6 months of stage I or stage II surgery
Incidence of seroma formation requiring intervention including aspiration in-office or ultrasound-guided drainage
次要结局
- Mean aspirations per seroma(Within 6 months of stage I or stage II surgery)
- Mean drain duration (Days)(Within 1 month of stage I or stage II surgery)
- Hematoma incidence(Within 1 month of stage I or stage II surgery)
- ADM integration assessment(Within 1 month of stage II procedure)
- Number of Participants with Implant loss(Within 2 year of stage II surgery)
- Number of Participants with Unplanned surgical care(Within 2 year of stage I or stage II surgery)
- Mean drain output (ml)(Within 1 month of stage I or stage II surgery)
- Mean seroma volume (ml)(Within 6 months of stage I or stage II surgery)
- Surgical site infection incidence(Within 6 months of stage I or stage II surgery)
- Number of Participants with Mastectomy flap necrosis(Within 1 month of stage I surgery)
- Pre and post-operative satisfaction assessed using BREAST-Q(Within 2 years of stage II surgery)
- Number of Participants with Red breast syndrome(Within 1 month of stage I surgery)
- Capsular contracture incidence(Within 1 year of stage II surgery)
- Post-operative aesthetic assessment (patient and surgeon)(Within 2 years of stage II surgery)
研究者
Nancy Van Laeken
Clinical Professor, Division of Plastic Surgery
University of British Columbia