At a glance
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Cold Versus Warm Tumescent Solution in Arm Liposculpture: A Double-blind Clinical Study.
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
Timeline
Interventions
Infiltration of cold tumescent solution at 4 C for lipoplasty.
Infiltration of warm tumescent solution at body temperature for lipoplasty.
Infiltration of tumescent solution in both arms, VASER fat emulsification then power-assisted liposuction of the arms.