Cold Versus Warm Tumescent Solution in Arm Liposculpture

NCT06865911 | Completed Phase 4

• 2 other identifiers: CP_ArmCOLD001Cold Arms
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tumescent solution; Arm liposculpture; Cold anesthesia; VASER-assisted lipoplasty; Liposuction outcomes

Outcome Measures

Primary Outcomes (3)

• Ecchymosis

  1\. Postoperative Bruising: Assessed using ImageJ software to quantify areas of bruising at Days 1, 3, and 7 postoperative.

  7 days

• Edema/inflammation

  2\. Inflammation: Measured via arm circumference on Days 1, 3, and 7.

  7 days

• Pain score

  3\. Postoperative pain: Scoring system using the visual analogue scale. From 1 to 10 at each time point: immediately after surgery, 1 ,3 and 7 days postoperative.

  7 days

Secondary Outcomes (2)

• Lipocrit evaluation

  6 hours

• Patient satisfaction

  30 days

Study Arms (2)

Cold tumescent solution

EXPERIMENTAL

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.

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

Warm tumescent solution

PLACEBO COMPARATOR

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.

Other: Warm saline; Procedure: Liposuction of the arms

Interventions

Cold crystalloid infusions, 0.9%NaCl or Ringer's OTHER

Infiltration of cold tumescent solution at 4 C for lipoplasty.

Also known as: Tumescent solution

Cold tumescent solution

Warm saline OTHER

Infiltration of warm tumescent solution at body temperature for lipoplasty.

Also known as: Warm tumescent solution

Warm tumescent solution

Liposuction of the arms PROCEDURE

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

Cold tumescent solution; Warm tumescent solution

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Eternal Beauty SAS: lead

Study Sites (1)

Dhara Clinic

Bogota DC, Bogota DC, 111111, Colombia

Location

Related Publications (4)

• Hoyos AE, Perez Pachon ME, Benavides JE, Eljaiek A, Borras Osorio M, Ramirez B. Effects of Optimal Temperature Control in Body Contouring Surgery: A Nonrandomized Controlled Clinical Trial. Aesthet Surg J. 2024 Oct 15;44(11):NP790-NP797. doi: 10.1093/asj/sjae142.

  PMID: 38953184 BACKGROUND

• Hoyos A, Perez M. Arm dynamic definition by liposculpture and fat grafting. Aesthet Surg J. 2012 Nov;32(8):974-87. doi: 10.1177/1090820X12461498.

  PMID: 23110928 BACKGROUND

• Cala Uribe LC, Perez Pachon ME, Babaitis R, Zannin Ferrero A, Aljure Diaz MF. Variable Energy and Ultrasound-based Liposculpture of the Arms: Multicenter and Multidevice Study. Plast Reconstr Surg Glob Open. 2024 Mar 19;12(3):e5649. doi: 10.1097/GOX.0000000000005649. eCollection 2024 Mar.

  PMID: 38948160 BACKGROUND

• Cala Uribe LC, Perez Pachon ME, Zannin Ferrero A, Neri Morales C, Silva Gutierrez J, Manrique Cruz AD, Maza MF, Acero Mondragon EJ, Celis Regalado LG. Effects of Bipolar Radiofrequency on Collagen Synthesis from Patients with Brachial Ptosis. Plast Reconstr Surg Glob Open. 2023 Apr 13;11(4):e4924. doi: 10.1097/GOX.0000000000004924. eCollection 2023 Apr.

  PMID: 37063507 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mauricio E Perez Pachon, MD

  Total Definer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Model Details: Prevention of excessive edema, pain and ecchymosis after liposculpture with the use of cold tumescent solution.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: January 12, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)