Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Presence of Hypertrophic Scarring
研究概览
简要总结
The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS).
Participants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.
详细描述
The hypothesis of this study is that the use of Brijjit® Force-Modulating Tissue Bridge devices will reduce the incidence of hypertrophic scarring as measured by objective and subjective factors compared to no intervention following gender-affirming double incision mastectomy. Patients will serve as self-controls (one side of the chest will receive the intervention, the other will not). Consistent use of silicone-based tape, the current gold standard for wound care, will be encouraged on the control side of the chest.
We hypothesize that applying FMTBs to surgical incisions will improve scar outcomes by limiting pro-fibrotic signaling and promoting optimal wound healing. Should our hypotheses be proven, this study will provide a compelling reason to implement Brijjit therapy into standard clinical practice as a non-invasive preventative measure to improve scar outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
While study participants cannot be blinded to the intervention, the operating surgeon will remain blinded to the patient's assignment until final skin closure at the end of the procedure.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing double incision gender affirming mastectomy
- •Ability to adhere to Brijjit therapy after surgery
- •Willing to return for follow-up visits and undergo study evaluations
排除标准
- •History of keloid formation
- •Radiation therapy history
- •Prior surgeries of the chest or breast
- •History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids
- •Active smoker
- •Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)
- •Any other condition determined by PI to preclude subject from joining study
研究组 & 干预措施
Self-control Brijjit Application and Control
The side of the chest that the Brijjit is applied to will be randomly allocated using a web-based, open-source randomizer. Initial application will be done intraoperatively, following final skin closure. Brijjit will be applied across the entire incision length. Following application, Brijjit has been shown to last for 2-4 weeks. Patients will remain in a chest vest binder with dressings until the initial follow-up visit at 2 weeks. At this follow up visit, any Brijjit that has fallen off will be replaced. Patients will be taught how to reapply Brijjit if it falls off, and they will be instructed to continue Brijjit therapy until 6 weeks post-op. Any remaining Brijjit devices will be removed at the 6 week post-op visit. At this time, patients will be able to initiate recommended scar care to both chest sides.
The control chest side will receive only standard of care and normal wound dressing.
干预措施: Brijjit® BP100-6 and BP-75 (Device)
Self-control Brijjit Application and Control
The side of the chest that the Brijjit is applied to will be randomly allocated using a web-based, open-source randomizer. Initial application will be done intraoperatively, following final skin closure. Brijjit will be applied across the entire incision length. Following application, Brijjit has been shown to last for 2-4 weeks. Patients will remain in a chest vest binder with dressings until the initial follow-up visit at 2 weeks. At this follow up visit, any Brijjit that has fallen off will be replaced. Patients will be taught how to reapply Brijjit if it falls off, and they will be instructed to continue Brijjit therapy until 6 weeks post-op. Any remaining Brijjit devices will be removed at the 6 week post-op visit. At this time, patients will be able to initiate recommended scar care to both chest sides.
The control chest side will receive only standard of care and normal wound dressing.
干预措施: Control: Standard of care and normal wound dressing (Other)
结局指标
主要结局
Presence of Hypertrophic Scarring
时间窗: 6 weeks postop
Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome.
Presence of Hypertrophic Scarring
时间窗: 3 months postop
Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome.
Presence of Hypertrophic Scarring
时间窗: 6 months postop
Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome.
Scar Characteristics
时间窗: 6 weeks postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Scar Characteristics
时间窗: 6 months postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Scar Dimensions
时间窗: 6 weeks postop
Scar Scar length, width and thickness measured in cm. If HTS present: Length of HTS and incision ratio Location of HTS: Medial, Middle, or Lateral. Measured distance from sternum.
Scar Dimensions
时间窗: 3 months postop
Scar Scar length, width and thickness measured in cm. If HTS present: Length of HTS and incision ratio Location of HTS: Medial, Middle, or Lateral. Measured distance from sternum.
Scar Dimensions
时间窗: 6 months postop
Scar Scar length, width and thickness measured in cm. If HTS present: Length of HTS and incision ratio Location of HTS: Medial, Middle, or Lateral. Measured distance from sternum.
Presence of Hypertrophic Scarring
时间窗: 1 year postop
Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome.
Scar Characteristics
时间窗: 1 year postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Scar characteristics
时间窗: 3 months postop
Qualitative description of scar: Scar color, pigmentation, texture, description (flat, thin, depressed, spread, raised)
Scar Dimensions
时间窗: 1 year postop
Scar Scar length, width and thickness measured in cm. If HTS present: Length of HTS and incision ratio Location of HTS: Medial, Middle, or Lateral. Measured distance from sternum.
次要结局
- Patient Perception of Scar(6 weeks postop)
- Patient Perception of Scar(3 months postop)
- Patient Perception of Scar(6 months postop)
- Patient Perception of Scar(1 year postop)
研究者
Esther Kim, MD
Esther A. Kim, MD
University of California, San Francisco