Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648265
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
EFFECTS of TRANEXAMIC ACID in TUMESCENT SOLUTION for LIPOSUCTION PROCEDURES
Sponsor:
None
Organization:
None
Study Overview
Official Title:
IMPACT of TRANEXAMIC ACID in TUMESCENT SOLUTION on POSTOPERATIVE OUTCOMES AFTER LIPOSUCTION a DOUBLE-BLIND CONTRALATERAL ARM RANDOMIZED CLINICAL TRIAL
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARMTXA
Brief Summary:
The goal of this trial is to evaluate the effect of adding Tranexamic Acid TXA to the tumescent solution used in arm liposuction on postoperative outcomes Study population includes healthy volunteer adults undergoing Liposculpture procedures The main question it aims to answer is
1 Does Tranexamic acid exert benefit on postoperative outcomes after liposuction Researchers will compare TXA versus traditional tumescent solution to see if there are benefits on adding it to the tumescent solution
Participants will undergo High Definition Liposculpture involving arms legs and their torso One arm will be infiltrated with traditional Kleins tumescent solution and the other one with the same one but adding Tranexamic Acid
1 Does Tranexamic acid exert benefit on postoperative outcomes after liposuction Researchers will compare TXA versus traditional tumescent solution to see if there are benefits on adding it to the tumescent solution
Participants will undergo High Definition Liposculpture involving arms legs and their torso One arm will be infiltrated with traditional Kleins tumescent solution and the other one with the same one but adding Tranexamic Acid
Detailed Description:
Study Design
Allocation Randomized one arm with TXA one without Intervention Model Crossover assignment each subject serves as their own control with one arm receiving TXA and the other not Masking Double-blind Participant and Outcomes Assessor
Interventions
Experimental Arm TXA Infiltration with Kleins tumescent solution 1000 ml of Ringers Lactate Epinephrine 1 mg Lidocaine 1 mg plus 250 mg of tranexamic acid
Control Arm Infiltration with Kleins tumescent solution 1000 ml of Ringers Lactate Epinephrine 1 mg Lidocaine 1 mg without tranexamic acid
Recruitment Information
Adults aged 18-60 undergoing elective High Definition liposuction No known allergies to TXA or lidocaine BMI of 30 kgm2
Study Start Date January 2022 Primary Completion Date January 2024 Study Completion Date June 2024 Study Locations Clinica Dhara Bogota DC Colombia
Data Collection Photomicrographic analysis with ImageJ Fiji Photos taken on days 1 3 and 7 will be processed to calculate the surface area of ecchymosis
Manual arm circumference measurements Measurements will be taken with a tape measure to monitor local swellinginflammation
Ethical Considerations
Informed Consent Participants will be provided with detailed information about the study and will be required to provide informed consent prior to participation
IRB Approval The trial will be conducted in compliance with ethical standards and will be reviewed and approved by an Institutional Review Board IRB
Allocation Randomized one arm with TXA one without Intervention Model Crossover assignment each subject serves as their own control with one arm receiving TXA and the other not Masking Double-blind Participant and Outcomes Assessor
Interventions
Experimental Arm TXA Infiltration with Kleins tumescent solution 1000 ml of Ringers Lactate Epinephrine 1 mg Lidocaine 1 mg plus 250 mg of tranexamic acid
Control Arm Infiltration with Kleins tumescent solution 1000 ml of Ringers Lactate Epinephrine 1 mg Lidocaine 1 mg without tranexamic acid
Recruitment Information
Adults aged 18-60 undergoing elective High Definition liposuction No known allergies to TXA or lidocaine BMI of 30 kgm2
Study Start Date January 2022 Primary Completion Date January 2024 Study Completion Date June 2024 Study Locations Clinica Dhara Bogota DC Colombia
Data Collection Photomicrographic analysis with ImageJ Fiji Photos taken on days 1 3 and 7 will be processed to calculate the surface area of ecchymosis
Manual arm circumference measurements Measurements will be taken with a tape measure to monitor local swellinginflammation
Ethical Considerations
Informed Consent Participants will be provided with detailed information about the study and will be required to provide informed consent prior to participation
IRB Approval The trial will be conducted in compliance with ethical standards and will be reviewed and approved by an Institutional Review Board IRB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None