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

Intervention / Treatment

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

  • Colombia
      • 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
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 Names:
  • Patient warming with Warm-air blankets
Experimental: Group 2
Passive measures
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 Names:
  • Patient warming with Warm-air blankets
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.
Other Names:
  • Patient warming with Warm-air Blankets
Experimental: Group 3
Active measures (Blanketrol)
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 Names:
  • Patient warming with Warm-air blankets
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.
Other Names:
  • Patient warming with Warm-air Blankets
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).
Other Names:
  • Patient warming with Warm-air Blankets
  • Fluid warming before infusion and infiltration
Experimental: Group 4
Active measures (HotDog)
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 Names:
  • Patient warming with Warm-air blankets
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.
Other Names:
  • Patient warming with Warm-air Blankets
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).
Other Names:
  • Patient warming with Warm-air Blankets
  • Fluid warming before infusion and infiltration

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

Total Definer Research Group

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

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

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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