The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients

Summary

The goal of this study is to perform a randomized clinical trial to assess the effects of vitamin C versus placebo on wound healing in mandibular fracture patients.

Conditions

• Vitamin C Deficiency
• Smoking
• Surgery
• Surgery--Complications
• Wound
• Wound Complication
• Wound Infection
• Wound Dehiscence
• Wound of Skin
• Mandible Fracture
• Mandible Open Fracture
• Mandible Closed Fracture
• Mandibular Fractures
• Ascorbic Acid Deficiency
• Oxidative Stress
• Inflammation

Interventions

DIETARY_SUPPLEMENT

Vitamin C

Just after induction of anesthesia in the OR, subjects will be administered a single intravenous (IV) dose of Vitamin C at 66mg/kg/hr for 2 hours during surgery. Post-operatively (beginning the morning after surgery) Vitamin C Treatment Group subjects will receive a 4 week prescription of oral, liquid Vitamin C, 500mg by mouth two times a day. These dosages are known to be safe and effective.89-91

OTHER

Placebo

Subjects will receive IV placebo (normal saline) identically packaged. Post-operatively Placebo Control Treatment Group participants will receive a 4-week prescription of the aqueous solution base used for the treatment group without the active component (Vitamin C).

Sponsors & Collaborators

• Regions Hospital

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• Hennepin Healthcare Research Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-12

Primary Completion

2021-06-01

Completion

2021-06-01

Countries

• United States

Study Locations