CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Cold crystalloid infusions, 0.9%NaCl or Ringer's +2 moreother
Likely dose
Cold crystalloid infusions, 0.9%NaCl or Ringer'sfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06865911
NCT06865911Phase 4Completed

Cold Versus Warm Tumescent Solution in Arm Liposculpture: A Double-blind Clinical Study.

Eternal Beauty SAS·interventional·Posted Mar 10, 2025·Updated Mar 11, 2025

In Brief

A Phase 4 clinical trial evaluating Cold crystalloid infusions, 0.9%NaCl or Ringer's, Warm saline, and 1 other intervention for Arm Pain and 3 related conditions. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesColombia
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMar 10, 2025
Enrollment StartJan 12, 2023
Primary CompletionApr 30, 2024
Study CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 1.3 years ago

Interventions

Cold crystalloid infusions, 0.9%NaCl or Ringer'sother

Infiltration of cold tumescent solution at 4 C for lipoplasty.

Warm salineother

Infiltration of warm tumescent solution at body temperature for lipoplasty.

Liposuction of the armsprocedure

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