Cold Versus Warm Tumescent Solution in Arm Liposculpture: a Double-blind Clinical Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Ecchymosis
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the temperature of tumescent solution (cold vs. warm) affects postoperative outcomes in adults undergoing arm liposculpture. The study includes men and women aged 18-60 years with certain body complexity, however no obese patients are allowed to enter the study. All patients are undergoing bilateral arm liposculpture as part of body contouring procedures.
The main questions it aims to answer are:
- Does using a cold tumescent solution reduce postoperative bruising compared to a warm solution?
- Does a cold tumescent solution reduce postoperative inflammation compared to a warm solution?
- How does solution temperature affect the quality of fat samples collected during liposuction?
Researchers will compare the cold tumescent solution group to the warm tumescent solution group to determine whether a lower temperature provides benefits in terms of reduced bruising, inflammation, and improved fat quality.
Participants will:
- Receive either a cold (4°C) or warm (room temperature) tumescent solution in each arm before liposuction.
- Undergo fat emulsification with VASER technology.
- Have one arm treated with Power-Assisted Liposuction (PAL) and the other with Conventional Suction-Assisted Liposuction (SAL).
- Have liposuction fat samples collected for analysis of fat content, blood content, and overall fat quality.
- Be monitored for bruising and inflammation on Days 1, 3, and 7 using an image analyzing software and arm circumference measurements.
- Complete a satisfaction survey 30 days after surgery.
Safety considerations include monitoring core temperature and using external warming devices if needed to prevent hypothermia.
详细描述
Study Objective:
To compare the effects of cold (4°C) and warm tumescent solutions in arm liposculpture on postoperative outcomes, specifically in terms of inflammation, bruising, and fat emulsification using different liposuction techniques.
Study Design
- Type: Interventional (Clinical Trial)
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double-blind (Participants and Surgeon)
- Primary Purpose: Prevention of complications
Population: Adults aged 18-60 years scheduled for bilateral arm liposculpture together with other body contouring procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-60 years.
- •Body mass index between 18 and
- •Patients scheduled for bilateral arm liposculpture together with other body contouring procedures.
- •Able to provide informed consent.
排除标准
- •History of coagulopathies.
- •ASA > II.
- •Allergies to tumescent solution components (epinephrine, lidocaine).
- •Pregnant or lactating individuals.
- •Previous surgeries on the arms.
研究组 & 干预措施
Cold tumescent solution
- Cold Tumescent Solution Group: Infiltration of tumescent solution at 4°C. Composition of tumescent solution: 1000 ml of Ringer's lactate + 7 ml of 2% Lidocaine without Epinephrine + 1 mg of Epinephrine + 250 mg of Tranexamic Acid.
干预措施: Cold crystalloid infusions, 0.9%NaCl or Ringer's (Other)
Cold tumescent solution
- Cold Tumescent Solution Group: Infiltration of tumescent solution at 4°C. Composition of tumescent solution: 1000 ml of Ringer's lactate + 7 ml of 2% Lidocaine without Epinephrine + 1 mg of Epinephrine + 250 mg of Tranexamic Acid.
干预措施: Liposuction of the arms (Procedure)
Warm tumescent solution
- Warm Tumescent Solution Group: Infiltration of tumescent solution at room temperature. Composition of tumescent solution: 1000 ml of Ringer's lactate + 7 ml of 2% Lidocaine without Epinephrine + 1 mg of Epinephrine + 250 mg of Tranexamic Acid.
干预措施: Liposuction of the arms (Procedure)
Warm tumescent solution
- Warm Tumescent Solution Group: Infiltration of tumescent solution at room temperature. Composition of tumescent solution: 1000 ml of Ringer's lactate + 7 ml of 2% Lidocaine without Epinephrine + 1 mg of Epinephrine + 250 mg of Tranexamic Acid.
干预措施: Warm saline (Other)
结局指标
主要结局
Ecchymosis
时间窗: 7 days
1. Postoperative Bruising: Assessed using ImageJ software to quantify areas of bruising at Days 1, 3, and 7 postoperative.
Edema/inflammation
时间窗: 7 days
2. Inflammation: Measured via arm circumference on Days 1, 3, and 7.
Pain score
时间窗: 7 days
3. Postoperative pain: Scoring system using the visual analogue scale. From 1 to 10 at each time point: immediately after surgery, 1 ,3 and 7 days postoperative.
次要结局
- Lipocrit evaluation(6 hours)
- Patient satisfaction(30 days)
研究者
Laura Cristina Cala Uribe
Plastic Surgeon
Eternal Beauty SAS