Cold Versus Warm Tumescent Solution in Arm Liposculpture

Summary

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.

Conditions

• Arm Pain
• Arm Aesthetics
• Liposuction
• Safety of Intervention

Interventions

OTHER

Cold crystalloid infusions, 0.9%NaCl or Ringer's

Infiltration of cold tumescent solution at 4 C for lipoplasty.

OTHER

Warm saline

Infiltration of warm tumescent solution at body temperature for lipoplasty.

PROCEDURE

Liposuction of the arms

Infiltration of tumescent solution in both arms, VASER fat emulsification then power-assisted liposuction of the arms.

Sponsors & Collaborators

• Eternal Beauty SAS

  lead OTHER

Principal Investigators

• Mauricio E Perez Pachon, MD · Total Definer

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-12

Primary Completion

2024-04-30

Completion

2024-06-30

Countries

• Colombia