NCT06865911

Cold Versus Warm Tumescent Solution in Arm Liposculpture

Completed Phase 4 Last updated 11 March 2025

What this trial tests

Phase 4 trial testing Cold crystalloid infusions, 0.9%NaCl or Ringer's in Arm Pain in 52 participants. Completed in 30 June 2024.

Timeline

12 January 2023

Primary endpoint
30 April 2024

30 June 2024

Quick facts

Lead sponsor	Eternal Beauty SAS
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	52
Start date	12 January 2023
Primary completion	30 April 2024
Estimated completion	30 June 2024
Sites	1 location across Colombia

Drugs / interventions tested

• Cold crystalloid infusions, 0.9%NaCl or Ringer's
• Warm saline — full drug profile →
• Liposuction of the arms

Conditions studied

• Arm Pain — all drugs for Arm Pain →
• Arm Aesthetics — all drugs for Arm Aesthetics →
• Liposuction — all drugs for Liposuction →
• Safety of Intervention — all drugs for Safety of Intervention →

Sponsor

Eternal Beauty SAS

Who can join

Adults 18 to 60, any sex, with Arm Pain or Arm Aesthetics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.