Clinical trial NCT06238739: Optimal Temperature Control in Body Contouring Procedures
Official title: Impact of Optimal Temperature Control in Body Contouring Surgery: A Non-Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Postoperative Pain
Postoperative Nausea
Postoperative Complications
Postoperative Shivering
Postoperative Hemorrhage
Keywords: Normothermia
Body contouring
Warming blankets
Safety
High-Definition Liposuction
Lead sponsor: Total Definer Research Group
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Hypothermia prevention
timeFrame: Before induction, Immediately after intubation, at the end of surgery (inside the OR), Upon arrival to the recovery room, before discharge.
measure: Pain intensity
timeFrame: Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge.
measure: Chills
timeFrame: Immediately at awakening at the recovery room.
measure: Shivering
timeFrame: Immediately at awakening at the recovery room.
measure: Recovery Period
timeFrame: Time interval, measured in minutes and hours, commencing from the patient's admittance into the Post-Anesthesia Care Unit (PACU) until their subsequent discharge.
measure: Analgesic requirements
timeFrame: Number of doses of pain medication required during the patient's recovery period at the PACU, between 1-8 hours after surgery.
Secondary outcomes:
measure: Cost-effectiveness of each intervention
timeFrame: Throughout the study completion, about 1 week.
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Dhara clinic
Study officials:
References:
citation: Hoyos AE, Duran H, Cardenas-Camarena L, Bayter JE, Cala L, Perez M, Lopez A, Talleri G, Dominguez-Millan R, Mogollon IR. Use of Tranexamic Acid in Liposculpture: A Double-Blind, Multicenter, Randomized Clinical Trial. Plast Reconstr Surg. 2022 Sep 1;150(3):569-577. doi: 10.1097/PRS.0000000000009434. Epub 2022 Jun 28.
citation: Enrique Bayter-Marin J, Cardenas-Camarena L, Pena WE, Duran H, Ramos-Gallardo G, Robles-Cervantes JA, McCormick-Mendez M, Rocio Gomez-Gonzalez S, Liliana Plata-Rueda E. Patient Blood Management Strategies to Avoid Transfusions in Body Contouring Operations: Controlled Clinical Trial. Plast Reconstr Surg. 2021 Feb 1;147(2):355-363. doi: 10.1097/PRS.0000000000007524.
citation: Bayter-Marin JE, Cardenas-Camarena L, Duran H, Valedon A, Rubio J, Macias AA. Effects of Thermal Protection in Patients Undergoing Body Contouring Procedures: A Controlled Clinical Trial. Aesthet Surg J. 2018 Mar 14;38(4):448-456. doi: 10.1093/asj/sjx155.