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

NCT03938584 | Completed

• 1 other identifier: HSR# 1-4276
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Procollagen I

  Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood serum.

  Blood is obtained the day of surgery and 6 weeks after surgery

• Procollagen III

  Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood serum.

  Blood is obtained the day of surgery and 6 weeks after surgery

Secondary Outcomes (14)

• Matrix Metallo-Proteinases 1,2,3 & 9

  Blood is obtained the day of surgery and 6 weeks after surgery

• C-reactive protein

  Blood is obtained the day of surgery and 6 weeks after surgery

• Neutrophil count

  Blood is obtained the day of surgery and 6 weeks after surgery

• Interleukins 6 & 8

  Blood is obtained the day of surgery and 6 weeks after surgery

• Thiobarbituric acid reactive substances

  Blood is obtained the day of surgery and 6 weeks after surgery

Other Outcomes (1)

• Wound score

  Wounds are analyzed 1 week and 6 weeks after surgery.

Study Arms (2)

Vitamin C

EXPERIMENTAL

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Vitamin C DIETARY_SUPPLEMENT

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

Also known as: Ascorbic Acid

Vitamin C

Placebo OTHER

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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients age 18 or older with de novo mandibular fracture undergoing surgical repair with an intra-oral incision based approach with plating (ie- not solely mandibular maxillary fixation which requires no surgical incision).,
• surgery within 7 days of injury.

You may not qualify if:

• cognitive impairment limiting ability to provide informed consent
• pregnancy or nursing
• a known history of renal insufficiency
• comminuted fractures,
• allergy to Vitamin C / placebo components.
• Isolated subcondylar fractures

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• Regions Hospital: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Ascorbic Acid Deficiency; Smoking; Wounds and Injuries; Wound Infection; Mandibular Fractures; Inflammation

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior; Infections; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 6, 2019
• Study Start: October 12, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)