NCT06238739

Optimal Temperature Control in Body Contouring Procedures

Impact of Optimal Temperature Control in Body Contouring Surgery: A Non-Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Total Definer Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Hypothermia
• Postoperative Pain
• Postoperative Nausea
• Postoperative Complications
• Postoperative Shivering
• Postoperative Hemorrhage

Interventions

Type	Name	Description
OTHER	Control - Standard Strategies for hypothermia prevention	Standard temperature management. Patients underwent one-hour pre- and post-operative warming with hot-air warming blankets at 38°C, without any other preoperative or intraoperative thermal protection measure.
OTHER	Fluid warming before infusion and infiltration	Passive Measures: Patients underwent one-hour preoperative warming with hot air warming blankets at 38°C (100.4°F), 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.
DEVICE	Thermal convection blanket by water flow (Blanketrol)	Blanketrol: Patients underwent continuous intra-operative temperature protection, using a thermal convection blanket by water flow (Blanketrol®) at 40°C (104°F).
DEVICE	Conductive fabric electric warming device (HotDog)	HotDog: Patients underwent permanent intra-operative thermal protection measures with conductive fabric electric warming device (HotDog®) at 40°C (104°F).

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2024-02-02
• Last updated: 2024-02-02

Locations

1 site across 1 country: Colombia