Clinical trial NCT06865911: Cold Versus Warm Tumescent Solution in Arm Liposculpture
Official title: Cold Versus Warm Tumescent Solution in Arm Liposculpture: A Double-blind Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arm Pain
Arm Aesthetics
Liposuction
Safety of Intervention
Keywords: Tumescent solution
Arm liposculpture
Cold anesthesia
VASER-assisted lipoplasty
Liposuction outcomes
Lead sponsor: Eternal Beauty SAS
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prevention of excessive edema, pain and ecchymosis after liposculpture with the use of cold tumescent solution.
Primary purpose: PREVENTION

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.

Detailed description: Study Objective:

To compare the effects of cold (4°C) and warm tumescent solutions in arm liposculpture on postoperative outcomes, specifically in terms of inflammation, bruising, and fat emulsification using different liposuction techniques.

Study Design

* Type: Interventional (Clinical Trial)
* Allocation: Randomized
* Intervention Model: Parallel Assignment
* Masking: Double-blind (Participants and Surgeon)
* Primary Purpose: Prevention of complications

Population: Adults aged 18-60 years scheduled for bilateral arm liposculpture together with other body contouring procedures.

Interventions

1. Cold Tumescent Solution Group (Intervention arm)

   o Infiltration of tumescent solution at 4°C.
2. Warm Tumescent Solution Group (Control arm) o Infiltration of standard tumescent solution (room temperature).

Tumescent Solution Composition (for both groups):

* 7 cc of 2% Lidocaine without Epinephrine.
* 1 mg of Epinephrine.
* 250 mg of Tranexamic Acid.

Procedure Outline

1. Infiltration Phase: Each arm is infiltrated with its respective tumescent solution (cold or warm). Allow a 15-minute diffusion period for the tumescent solution to take effect.
2. VASER Emulsification: Apply VASER technology to both arms at 50% power for fat emulsification.
3. Liposuction Techniques: Arm A: Liposculpture performed using Power-Assisted Liposuction (PAL). Arm B: Liposculpture performed using Conventional Suction-Assisted Liposuction (SAL).
4. Fat is collected separately for each arm and stored in individual containers.
5. Sample Collection for Analysis:

   * Collect a lipocrit sample in a 10 ml syringe from each arm.
   * Send the samples to pathology for analysis of fat content, blood content, and overall quality of the liposuction sample.

Primary Outcome Measures

1. Postoperative Bruising: Assessed using ImageJ software to quantify areas of bruising at Days 1, 3, and 7 postoperative.
2. Inflammation: Measured via arm circumference on Days 1, 3, and 7.
3. Quality of Fat Samples: Pathological evaluation of fat and blood content from the lipocrit samples.

Secondary Outcome Measures

1. Patient Satisfaction: Surveys conducted 30 days post-procedure.
2. Complication Rates: Hematoma, seroma, and infection rates evaluated within 30 days post-op.

Safety Considerations:

Surgeons must be cautious when using cold tumescent solutions due to the risk of hypothermia, particularly during extended procedures. Continuous core temperature monitoring and the use of external warming devices are recommended to mitigate the risks of lowering core temperature.

Timeline:

* Start Date: January 2023
* Primary Completion Date: December 2023
* Study Completion Date: June 2024

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Ecchymosis
timeFrame: 7 days
measure: Edema/inflammation
timeFrame: 7 days
measure: Pain score
timeFrame: 7 days
Secondary outcomes:
measure: Lipocrit evaluation
timeFrame: 6 hours
measure: Patient satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
city: Bogota DC
country: Colombia
facility: Dhara Clinic
Study officials:
affiliation: Total Definer
name: Mauricio E Perez Pachon, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.