Optimal Temperature Control in Body Contouring Procedures
January 31, 2024 updated by: Alfredo Hoyos, Total Definer Research Group
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.
Study Overview
Status
Completed
Conditions
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).
Study Type
Interventional
Enrollment (Actual)
197
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bogota, Colombia
- Dhara clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Group 1
Standard measures administered to patients
|
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 Names:
|
|
Experimental: Group 2
Passive measures
|
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 Names:
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.
Other Names:
|
|
Experimental: Group 3
Active measures (Blanketrol)
|
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 Names:
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.
Other Names:
Blanketrol: Patients underwent continuous intra-operative temperature protection, using a thermal convection blanket by water flow (Blanketrol®) at 40°C (104°F).
Other Names:
|
|
Experimental: Group 4
Active measures (HotDog)
|
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 Names:
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.
Other Names:
HotDog: Patients underwent permanent intra-operative thermal protection measures with conductive fabric electric warming device (HotDog®) at 40°C (104°F).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hypothermia prevention
Time Frame: Before induction, Immediately after intubation, at the end of surgery (inside the OR), Upon arrival to the recovery room, before discharge.
|
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.
|
|
Pain intensity
Time Frame: Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge.
|
Visual analogue scale rating
|
Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge.
|
|
Chills
Time Frame: Immediately at awakening at the recovery room.
|
Yes or NO
|
Immediately at awakening at the recovery room.
|
|
Shivering
Time Frame: Immediately at awakening at the recovery room.
|
Yes or NO
|
Immediately at awakening at the recovery room.
|
|
Recovery Period
Time Frame: Time interval, measured in minutes and hours, commencing from the patient's admittance into the Post-Anesthesia Care Unit (PACU) until their subsequent discharge.
|
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.
|
|
Analgesic requirements
Time Frame: Number of doses of pain medication required during the patient's recovery period at the PACU, between 1-8 hours after surgery.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost-effectiveness of each intervention
Time Frame: Throughout the study completion, about 1 week.
|
Analysis of overall costs and effects on patient recovery among the different groups.
|
Throughout the study completion, about 1 week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
July 30, 2023
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
December 9, 2023
First Submitted That Met QC Criteria
January 31, 2024
First Posted (Estimated)
February 2, 2024
Study Record Updates
Last Update Posted (Estimated)
February 2, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NormoT001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Depending upon reasonable request
IPD Sharing Time Frame
Immediately after publication.
IPD Sharing Access Criteria
Request to the main author
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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