Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238739
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2023-12-09
Brief Title:
Optimal Temperature Control in Body Contouring Procedures
Sponsor:
Total Definer Research Group
Organization:
Total Definer Research Group
Study Overview
Official Title:
Impact of Optimal Temperature Control in Body Contouring Surgery A Non-Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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
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 38C 1004F the operating room OR temperature was maintained at a minimum of 21C 698F asepticantiseptic solutions along with infiltration fluid were all warmed to 38C 1004F 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 40C 104F 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 40C 104F
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None