A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Scar cosmesis (SCAR scale)
研究概览
简要总结
This study will compare the cosmetic scar result from the use of scalpel, electrocautery, and pulsed electron avalanche knife (PEAK) PlasmaBlade (PPB) for the initial skin incision for total mastectomy procedures without immediate breast reconstruction.
It is hypothesized that there will be no significant difference in mastectomy scar cosmesis.
The purpose and objectives of this study are:
- To evaluate and compare the cosmetic scar result from the use of scalpel, standard electrocautery, or PEAK PlasmaBlade for initial incision for total mastectomy procedures without immediate breast reconstruction.
- To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.
详细描述
Scalpel, electrocautery, and PEAK PlasmaBlade (PPB) have all been shown to be safe techniques for surgical incision, but no study has proven the superiority for cosmesis for PPB incision when compared to conventional electrocautery or scalpel.
The investigators propose a double blind prospective randomized controlled study of consecutive patients scheduled for total mastectomy +/- axilla staging without immediate breast reconstruction to evaluate the cosmetic scar result from the use of scalpel, standard electrocautery or PEAK PlasmaBlade.
Scar cosmesis will be evaluated postoperatively at two-to-four weeks, six months, and twelve months by two independent observers blinded to the equipment used, and patient reported outcomes will be reported using the validated SCAR-Q questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having a total mastectomy with or without axilla surgical staging
排除标准
- •Patients having immediate breast reconstruction
- •Patients with a diagnosis of inflammatory breast cancer
- •History of keloid scar formation
- •History of connective tissue disorder (scleroderma or rheumatoid arthritis with skin involvement)
- •Patients with prior incision at the planned mastectomy site.
- •Patients with known suture hypersensitivity
- •Patients with evidence of current infection
结局指标
主要结局
Scar cosmesis (SCAR scale)
时间窗: 12 months post-operatively
Mastectomy site scar cosmesis will be evaluated 12 months post-operatively by two independent observers blinded to the equipment used for the surgery using photo evaluation with the Scar Cosmesis Assessment and Rating (SCAR) scale. The SCAR scale yields scores ranging from a minimum score of 0 (best possible scar) to a maximum score of 15 (worst possible scar).
Scar cosmesis (Vancouver Scar Scale)
时间窗: 12 months post-operatively
Mastectomy site scar cosmesis will be evaluated 12 months post-operatively by the treating surgeon using the Vancouver Scar Scale for physical examination. The Vancouver Scar Scale yields scores ranging from 0 (best) to 13 (worst).
Scar cosmesis (SCAR-Q)
时间窗: 12 months post-operatively
Patient reported outcomes will be reported 12 months post-operatively using the SCAR-Q scale, a comprehensive scar appearance scale with independently functioning domains for scar appearance, scar symptoms and psychosocial impact, which each yield transformed scores ranging from 0 (worst) to 100 (best).
次要结局
- Development of cellulitis(within 12 months post-operatively)
- Wound infection rate(within 12 months post-operatively)
- Length of operative procedure(beginning to end of operative procedure)
- Peri-operative pain(from end of operative procedure to 2 weeks post-operatively)
- Development of post-operative seroma(within 12 months post-operatively)
- Development of post-operative hematoma(within 12 months post-operatively)
- Development of excessive bruising(within 12 months post-operatively)
- Development of flap necrosis(within 12 months post-operatively)
- Development of wound dehiscence(within 12 months post-operatively)
- Delayed healing(within 12 months post-operatively)
- Volume of measured drainage(from drain placement to drain removal, up to 1 month)
- Intraoperative blood loss(beginning to end of operative procedure)
- Duration of drain(from drain placement to drain removal, up to 1 month)
研究者
Carol Dingee
Breast Surgical Oncologist, Principal Investigator, Clinical Professor
University of British Columbia