Optimal Temperature Control in Body Contouring Procedures

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06238739
• Other study ID #: NormoT001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: January 2024
• Source: Total Definer Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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).
• 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).

Locations

Country	Name	City	State
Colombia	Dhara clinic	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Total Definer Research Group

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

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. — View 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 Operation — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothermia prevention	Measure the body temperature throughout the procedure	Before induction, Immediately after intubation, at the end of surgery (inside the OR), Upon arrival to the recovery room, before discharge.
Primary	Pain intensity	Visual analogue scale rating	Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge.
Primary	Chills	Yes or NO	Immediately at awakening at the recovery room.
Primary	Shivering	Yes or NO	Immediately at awakening at the recovery room.
Primary	Recovery Period	Time from Operating Room to discharge from the recovery room.	Time interval, measured in minutes and hours, commencing from the patient's admittance into the Post-Anesthesia Care Unit (PACU) until their subsequent discharge.
Primary	Analgesic requirements	Measure the amount of analgesic required for pain control	Number of doses of pain medication required during the patient's recovery period at the PACU, between 1-8 hours after surgery.
Secondary	Cost-effectiveness of each intervention	Analysis of overall costs and effects on patient recovery among the different groups.	Throughout the study completion, about 1 week.