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Impact of Optimal Temperature Control in Body Contouring Surgery: A Non-Randomized Controlled Clinical Trial
The goal of this clinical trial is to compare different strategies for normothermia prevention in patients undergoing body contouring and other Aesthetic Plastic Surgery procedures. The main question(s) it aims to answer are: * Do active measures have an impact on preventing hypothermia in patients undergoing cosmetic procedures? * Does an active normothermia prevention protocol have any impact in the clinical setting? Four different protocols will be used for patient peroperative preparation for normothermia.
Participants will receive either of four different protocols for normothermia: Group 1 (Control) involved patients with standard temperature management according to regular institutional protocol, without preoperative or intraoperative thermal protection measures. Group 2 (Passive thermal protection measures) had patients who underwent one-hour preoperative warming with hot air at 38°C (100.4°F), the operating room (OR) temperature was maintained at a minimum of 21°C (69.8°F), aseptic/antiseptic solutions along with infiltration fluid were all warmed to 38°C (100.4°F), and surgical fields were kept as dry as possible. In Group 3 (Active thermal protection measures), patients received the same measures as Group 2, adding continuous intraoperative temperature protection, using a thermal convection blanket by water flow (Blanketrol®) at 40°C (104°F). Group 4 (active thermal protection measures) included patients with the same measures as Group 2, adding permanent intraoperative thermal protection measures with conductive fabric electric warming device (HotDog®) at 40°C (104°F).
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
Yes
Dhara clinic
Bogotá, Colombia
Start Date
June 1, 2022
Primary Completion Date
July 30, 2023
Completion Date
July 30, 2023
Last Updated
February 2, 2024
197
ACTUAL participants
Control - Standard Strategies for hypothermia prevention
OTHER
Fluid warming before infusion and infiltration
OTHER
Thermal convection blanket by water flow (Blanketrol)
DEVICE
Conductive fabric electric warming device (HotDog)
DEVICE
Lead Sponsor
Total Definer Research Group
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07327463