Cold Versus Warm Tumescent Solution in Arm Liposculpture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Liposuction for Arm Lymphedema Following Breast Cancer Surgery

NCT00816985

Breast Cancer

COMPLETED NA

Supervised Resistance TRaining amONG Women at Risk of Breast Cancer Related Lymphedema

NCT04821609

Breast Cancer Physical Activity Lymphedema of Upper Arm

UNKNOWN NA

Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome

NCT05920369

Axillary Web Syndrome

UNKNOWN NA

Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection

NCT00984269

Lymphedema

ACTIVE_NOT_RECRUITING NA

Liposuction as Treatment for Excessive Axillary Sweat

NCT00228072

Hyperhidrosis

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arm Pain Arm Aesthetics Liposuction Safety of Intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cold tumescent solution

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.

Group Type EXPERIMENTAL

Cold crystalloid infusions, 0.9%NaCl or Ringer's

Intervention Type OTHER

Infiltration of cold tumescent solution at 4 C for lipoplasty.

Liposuction of the arms

Intervention Type PROCEDURE

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

Warm tumescent solution

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.

Group Type PLACEBO_COMPARATOR

Warm saline

Intervention Type OTHER

Infiltration of warm tumescent solution at body temperature for lipoplasty.

Liposuction of the arms

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cold crystalloid infusions, 0.9%NaCl or Ringer's

Infiltration of cold tumescent solution at 4 C for lipoplasty.

Intervention Type OTHER

Warm saline

Infiltration of warm tumescent solution at body temperature for lipoplasty.

Intervention Type OTHER

Liposuction of the arms

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tumescent solution Warm tumescent solution

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes