Status:
UNKNOWN
Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery
Lead Sponsor:
University of Malaya
Conditions:
Oxidative Stress
Ischemia-reperfusion Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Ischemia and reperfusion injury during free flap reconstructive surgery creates a state of increased oxidative stress that can adversely affect the flap outcomes. Ascorbic acid (AA) had been proven to...
Detailed Description
Temporary cessation of blood supply to the flap tissues from clamping of donor vascular pedicle (ischemia) followed by restoration of flap tissue perfusion (reperfusion) after micro-anastomosis are in...
Eligibility Criteria
Inclusion
- \- Adults (age 18 years and older, male or female) who are planned for elective free flap reconstructive surgery.
Exclusion
- Hypersensitivity to vitamin C
- Oliguria (urine output \<400mL/day) or anuria (urine output \<100mL/day)
- Renal failure (serum creatinine level ≥175.0 %mol/L)
- Hemodialysis
- Renal calculi
- Thalassemia
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Unfit for surgery
- Pregnancy or lactating
- Hemochromatosis
- Hyperoxaluria
Key Trial Info
Start Date :
September 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05327348
Start Date
September 25 2022
End Date
July 31 2023
Last Update
November 25 2022
Active Locations (3)
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1
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
2
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
3
University of Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100