Optimal Temperature Control in Body Contouring Procedures

Total Definer Research Group

Status: Completed

Conditions: Postoperative Complications; Postoperative Pain; Postoperative Shivering; Postoperative Hemorrhage; Hypothermia; Postoperative Nausea

Treatments: Device: Thermal convection blanket by water flow (Blanketrol); Device: Conductive fabric electric warming device (HotDog); Other: Fluid warming before infusion and infiltration; Other: Control - Standard Strategies for hypothermia prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT06238739

NormoT001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 197 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing body contouring procedures (liposuction or liposculpture), either individually or combined with a maximum of two other major aesthetic procedures involving face, breast, or dermolipectomy.
• Healthy patients without underlying comorbidities (classified as ASA≤II)

Exclusion criteria

• Women with BMI >30 kg/m²
• men with BMI >32 kg/m²
• Patients after massive weight loss
• Smokers

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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197 participants in 4 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

Standard measures administered to patients

Treatment:

Other: Control - Standard Strategies for hypothermia prevention

Group 2

Experimental group

Description:

Passive measures

Treatment:

Other: Control - Standard Strategies for hypothermia prevention

Other: Fluid warming before infusion and infiltration

Group 3

Experimental group

Description:

Active measures (Blanketrol)

Treatment:

Other: Control - Standard Strategies for hypothermia prevention

Other: Fluid warming before infusion and infiltration

Device: Thermal convection blanket by water flow (Blanketrol)

Group 4

Experimental group

Description:

Active measures (HotDog)

Treatment:

Other: Control - Standard Strategies for hypothermia prevention

Device: Conductive fabric electric warming device (HotDog)

Other: Fluid warming before infusion and infiltration