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Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery

NCT05327348 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-11-25

No results posted yet for this study

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 have beneficial effect on end-organ protection and flap survival from ischemia-reperfusion injury via its antioxidant properties.

The investigators hypothesise that perioperative parenteral ascorbic acid treatment may reduce oxidative stress among participants undergoing free flap reconstructive surgery along with reduction in inflammatory markers, improved rate of flap viability and wound healing at both donor and recipient sites.

Conditions

  • Oxidative Stress
  • Ischemia-reperfusion Injury

Interventions

DRUG

Intravenous Ascorbate

Intravenous ascorbic acid 1 gram 8 hourly (3 grams per day) over 15 minutes for 7 days since pre-operative day 1 until post-operative day 5.

DRUG

Normal Saline 10 mL Injection

Intravenous 0.9% normal saline 8 hourly bolus infusion over 15 minutes for 7 days since pre-operative day 1 until post-operative day 5.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Raymond Yii Shi Liang, MBBS · University of Malaya Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-25
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Malaysia

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 NCT05327348 on ClinicalTrials.gov