Bridging the Healing Gap: A Single-Blind Clinical Trial Assessing the Efficacy of Carboxy-gel in Reducing Bruising and Pain Post-Liposuction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Ecchymosis of the area - 7 days post procedure
研究概览
简要总结
The goal of this clinical trial is to evaluate if CO2 Lift reduces bruising and pain after Liposuction. The study also aims to explore changes in patient satisfaction. The main questions this study seeks to answer are:
- Does CO2 lift reduce the extent of bruising at 7 days post-surgery?
- How does CO2 lift impact patient-reported pain and satisfaction?
In this study, researchers will compare CO2 lift to a placebo (Vaseline) to see if the intervention has a positive effect.
The study procedures include:
- Baseline data collection of sociodemographic variables. Data collection of surgical variables, adverse events, pain scores, and satisfaction scores.
- During the liposuction procedure the patient will receive CO2 Lift application to one arm, and/or one glute, and/or one half of the lower abdomen, and placebo (Vaseline) to the contralateral part.
- Apply CO2 lift and Vaseline immediately after surgery, 12 hours later, and then once a day for 3 to 5 days depending of the risk of the flap/skin.
- Postoperative follow-up with photos of treated areas at 24 hours, 3 days, and 7 days, with bruising quantified using Image J software.
详细描述
Study Design: Randomized, controlled, single-blind trial
- Allocation: Randomized (one area with CO2 lift treatment, one area with Vaseline control)
- Intervention Model: Comparative contralateral randomized clinical trial (each participant serves as their own control, with CO2 lift applied to one area and Vaseline to the contralateral area).
- Masking: Single-blind (Participants are blinded to the treatment allocation).
Study Locations:
- Dhara Clinic, Bogota, Colombia
- Private Practice, Sao Paulo, Brazil
- Private Practice, Mexico City, Mexico
Data Collection:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing body contouring procedures (liposuction or liposculpture), either individually or combined with a maximum of two other major aesthetic procedures involving face, breast, or dermo-lipectomy.
- •healthy patients without underlying comorbidities (classified as ASA≤II)
排除标准
- •Pregnant patients
- •Known allergy to CO2 Lift or Vaseline
- •History of keloid formation or significant dermatological conditions.
- •Coagulopathy or current use of anticoagulant therapy.
- •Skin disorders related to collagen disease.
- •BMI ≥ 32 kg/m2.
研究组 & 干预措施
CO2 Lift group
- Application of CO2 lift to one arm, and/or one glute, and/or one half of the lower abdomen.
- Apply immediately after surgery and 12 hours later. Then one time per day for 3-5 days for patients with low risk for flap/skin ischemia/suffering.
干预措施: Carboxytherapy (Drug)
Control group
* Application of Vaseline to the contralateral area in which CO2 lift was applied, using the same timing protocol as per CO2 lift
干预措施: Placebo (Other)
结局指标
主要结局
Ecchymosis of the area - 7 days post procedure
时间窗: 7 days
Reduction of ecchymosis in each area, measured using Photomicrographic analysis with ImageJ Software. The unit of measurement will me in cm\^2 of the affected area (bruised) normalized to the total area of the area (in cm\^2).
次要结局
- Ecchymosis of the area - 24 hours post procedure(24 hours)
- Ecchymosis of the area - 3 days post procedure(3 days)
- Pain Score(7 days)
- Patient Satisfaction Scores(6 months)
研究者
Alfredo Hoyos
Plastic Surgeon
Total Definer Research Group