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Optimal Temperature Control in Body Contouring Procedures

NCT06238739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2024-02-02

No results posted yet for this study

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.

Conditions

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

Interventions

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

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).

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).

Sponsors & Collaborators

  • Total Definer Research Group

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-07-30
Completion
2023-07-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06238739 on ClinicalTrials.gov