Cold Versus Warm Tumescent Solution in Arm Liposculpture

Eternal Beauty SAS

Status and phase: Completed; Phase 4

Conditions: Safety of Intervention; Liposuction; Arm Pain; Arm Aesthetics

Treatments: Procedure: Liposuction of the arms; Other: Cold crystalloid infusions, 0.9%NaCl or Ringer's; Other: Warm saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06865911

Cold Arms (Other Identifier)

CP_ArmCOLD001

Details and patient eligibility

About

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.

Full description

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.

Interventions

1. Cold Tumescent Solution Group (Intervention arm)

   o Infiltration of tumescent solution at 4°C.

2. Warm Tumescent Solution Group (Control arm) o Infiltration of standard tumescent solution (room temperature).

Tumescent Solution Composition (for both groups):

• 7 cc of 2% Lidocaine without Epinephrine.
• 1 mg of Epinephrine.
• 250 mg of Tranexamic Acid.

Procedure Outline

1. Infiltration Phase: Each arm is infiltrated with its respective tumescent solution (cold or warm). Allow a 15-minute diffusion period for the tumescent solution to take effect.

2. VASER Emulsification: Apply VASER technology to both arms at 50% power for fat emulsification.

3. Liposuction Techniques: Arm A: Liposculpture performed using Power-Assisted Liposuction (PAL). Arm B: Liposculpture performed using Conventional Suction-Assisted Liposuction (SAL).

4. Fat is collected separately for each arm and stored in individual containers.

5. Sample Collection for Analysis:

   • Collect a lipocrit sample in a 10 ml syringe from each arm.
   • Send the samples to pathology for analysis of fat content, blood content, and overall quality of the liposuction sample.

Primary Outcome Measures

1. Postoperative Bruising: Assessed using ImageJ software to quantify areas of bruising at Days 1, 3, and 7 postoperative.
2. Inflammation: Measured via arm circumference on Days 1, 3, and 7.
3. Quality of Fat Samples: Pathological evaluation of fat and blood content from the lipocrit samples.

Secondary Outcome Measures

1. Patient Satisfaction: Surveys conducted 30 days post-procedure.
2. Complication Rates: Hematoma, seroma, and infection rates evaluated within 30 days post-op.

Safety Considerations:

Surgeons must be cautious when using cold tumescent solutions due to the risk of hypothermia, particularly during extended procedures. Continuous core temperature monitoring and the use of external warming devices are recommended to mitigate the risks of lowering core temperature.

Timeline:

• Start Date: January 2023
• Primary Completion Date: December 2023
• Study Completion Date: June 2024

Enrollment: 52 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18-60 years.
• Body mass index between 18 and 30.
• Patients scheduled for bilateral arm liposculpture together with other body contouring procedures.
• Able to provide informed consent.

Exclusion criteria

• History of coagulopathies.
• ASA > II.
• Allergies to tumescent solution components (epinephrine, lidocaine).
• Pregnant or lactating individuals.
• Previous surgeries on the arms.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Cold tumescent solution

Experimental group

Description:

1. 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.

Treatment:

Other: Cold crystalloid infusions, 0.9%NaCl or Ringer's

Procedure: Liposuction of the arms

Warm tumescent solution

Placebo Comparator group

Description:

2. 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.

Treatment:

Other: Warm saline

Procedure: Liposuction of the arms