Use of MIST Ultrasound Therapy to Minimize Edema, Bruising and Scarring After Cosmetic Surgery Procedures of the Face and Body
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,440
- 试验地点
- 2
- 主要终点
- Reduction in wound healing complications
研究概览
简要总结
A clinical trial to evaluate the effect of MIST Therapy on outcomes after cosmetic procedures(including facelifts, blepharoplasties, breast augmentations and reductions, mastopexies, and abdominoplasties) traditionally associated with pain, swelling, bruising, and scarring. The study will test the hypothesis that MIST Therapy can decrease the incidence and severity of these surgical sequelae throughout the acute and sub-acute phases of healing.
详细描述
A post-market, single-center, prospective, randomized, single-blinded study.
Each subject serves as her/his own control. The procedures chosen are bilateral, and each subject will have one side of the surgical site treated with MIST Therapy and the other side left untreated except for the surgeon's usual postoperative care protocol.
Study objectives: Comparison between MIST-treated side versus the contralateral untreated side on the reduction in swelling, bruising, firmness, pain, and wound healing complications; the potential improvements in scarring; and the improvements in patient satisfaction.
Subject recruitment: A total of 30 subjects will be enrolled into the study. The MIST-treated side will be randomly assigned. The assigned MIST-treated side will be known to the subject and assistant providing MIST Therapy, but will not be known to the Investigator/assessor.
Protocol and procedures: Subjects will be followed until 12 weeks post-surgery. The side assigned for MIST Therapy treatment will be treated weekly, beginning 2-3 days post-surgery, and continuing until 3 weeks post-surgery. A baseline evaluation will include demographic data, medical and surgical history, smoking history, laboratory tests, and digital photography of each side of the wound.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be between 18-75 years of age
- •Subject must be compliant with the study visits
- •Subject must be in good health
- •Subject must be able to provide written informed consent
- •Subject must be undergoing one or more of the following bilateral procedures:
- •Rhytidectomies
- •Blepharoplasty
- •Breast augmentation
- •Mastopexy
- •Breast reduction
- •Abdominoplasty
排除标准
- •Subject has any medical condition that would result in poor wound healing
- •Subject has any medical condition that would result in poor scarring
- •Subject is taking medications that may affect healing or scarring, including Arnica
- •Subject has diabetes
- •Area to be treated has been irradiated
- •Subject is undergoing a secondary procedure that may be associated with prior scar tissue in the area undergoing surgery
- •Subject has any medical condition that in the opinion of the Investigator would make the subject an inappropriate candidate for this study, including a higher than usual concern for surgical complications
- •Subject has electronic implants or prosthesis
- •Subject has cardiac pacemaker
- •Pregnant woman
- •Skin cancer
结局指标
主要结局
Reduction in wound healing complications
时间窗: 12 weeks
Outcome measured by wound evaluations assessing wound dehiscences, suture spitting, and localized wound infections.
Reduction in swelling, bruising, firmness and pain
时间窗: 2-6 weeks
Outcomes measured by * Subject-completed pain and swelling assessments * Observer-completed bruising, swelling and firmness assessments
Improvements in scarring
时间窗: 12 weeks
Outcome measured by Subject-completed and Observer-completed scar assessment scales.
次要结局
- Patient satisfaction(12 weeks)