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

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ClinicalTrials.gov Identifier: NCT03938584
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
Regions Hospital
University of Minnesota, MN
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute.

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.

Condition or disease Intervention/treatment Phase
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 Dietary Supplement: Vitamin C Other: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients: A Double Blind, Placebo-controlled Randomized Clinical Trial
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Vitamin C 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 Name: Ascorbic Acid

Placebo Comparator: Placebo 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).




Primary Outcome Measures :
  1. Procollagen I [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood serum.

  2. Procollagen III [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood serum.


Secondary Outcome Measures :
  1. Matrix Metallo-Proteinases 1,2,3 & 9 [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood

  2. C-reactive protein [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of soft tissue repair. Measured in nanogram/milliliter (ng/ml) in blood

  3. Neutrophil count [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood

  4. Interleukins 6 & 8 [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood

  5. Thiobarbituric acid reactive substances [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of soft tissue repair. Measured in micro Molar uM in blood

  6. Trolox equivalent antioxidant capacity [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of soft tissue repair. Measured in nanomol/microliter (nmol/ul) in blood

  7. alkaline phosphatase [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of bone repair. Measured in enzyme unit/liter (U/L) in blood

  8. Tartrate Resistant Acid Phosphatase 5b [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of bone repair. Measured in enzyme unit/liter (U/L) in blood

  9. osteocalcin [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of bone repair. Measured in picogram/milliliter (pg/ml) in blood

  10. osteoprotegerin [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of bone repair. Measured in picogram/milliliter (pg/ml) in blood

  11. carboxy terminal collagen crosslinks [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of bone repair. Measured in nanogram/milliliter (ng/ml) in blood

  12. Receptor activator of nuclear factor kappa-B ligand [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of bone repair. Measured in picogram/milliliter (pg/ml) in blood

  13. Vitamin C [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Vitamin C levels. Measured in nanomols (nmmol) in blood serum

  14. Cotinine [ Time Frame: Blood is obtained the day of surgery and 6 weeks after surgery ]
    Biomarker of tobacco exposure. Measured in nanograms/milliliter (mg/ml) in blood serum.


Other Outcome Measures:
  1. Wound score [ Time Frame: Wounds are analyzed 1 week and 6 weeks after surgery. ]
    Wounds are scored from photographs using the InCISE wound score developed by the investigator.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938584


Contacts
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Contact: Anna C Research Coordinator, BS 612-873-5329 anna.wilson@hcmed.org
Contact: Amy Anne D Investigator, MD, MS

Locations
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United States, Minnesota
Hennepin Healthcare Research Institute Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Anna C Research Coordinator, BS    612-873-5329    anna.wilson@hcmed.org   
Principal Investigator: Amy Anne D Lassig, MD, MS         
Sponsors and Collaborators
Hennepin Healthcare Research Institute.
Regions Hospital
University of Minnesota, MN

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Responsible Party: Hennepin Healthcare Research Institute.
ClinicalTrials.gov Identifier: NCT03938584     History of Changes
Other Study ID Numbers: HSR# 1-4276
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wound Infection
Mandibular Fractures
Scurvy
Ascorbic Acid Deficiency
Inflammation
Fractures, Bone
Fractures, Open
Fractures, Closed
Wounds and Injuries
Pathologic Processes
Infection
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Vitamins
Ascorbic Acid
Micronutrients