Trauma Screening and Supplementation
Condition: Trauma; Nutritional Deficiency; Wound Heal
MeSH terms: Malnutrition; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of the proposed study is twofold: 1) The investigators will evaluate ultrasound
      imaging to screen trauma patients to identify patients at increased risk of postoperative
      complications associated with sarcopenia. 2) The investigators will evaluate a
      commercially-available oral nutritional supplement that has previously been evaluated in
      critically-ill intensive care patients and shown benefit for decreasing complications
      including decreased wound healing complications, decreased pressure ulcers, decreased
      skeletal muscle loss due to immobilization, and decreased one-year mortality.
    

Detailed description: 
      Following consent, patients will be assigned a unique study identification number (ID). A
      master list linking patient ID to patient name and medical record number will be maintained
      on a password protected and encrypted departmental server location with access limited to
      research staff. Patients will be randomized by the research team using Microsoft Word random
      number generator. Patients will not be blinded to their research group, as the experimental
      nutrition supplementation group will be asked to consume the nutritional supplement daily for
      a period of two weeks following surgery.

      Following consent, the patient's medical record will be reviewed to identify any condition
      meeting exclusion criteria. If patient meets inclusion criteria we will obtain the following
      data to be recorded in the research database.

        1. Age

        2. Sex

        3. Height

        4. Weight

        5. BMI

        6. medical comorbidities necessary to calculate Charlson Comorbidity Index (myocardial
           infarction, congestive heart failure, peripheral vascular disease, cerebrovascular
           disease, dementia, chronic pulmonary disease, rheumatologic disorder, peptic ulcer
           disease, diabetes without chronic complications, diabetes with chronic complications,
           hemiplegia or paraplegia, renal disease, any malignancy, metastatic solid tumor, mild
           liver disease, moderate or severe liver disease, HIV/AIDS

        7. MSSA (methicillin-susceptible Staphylococcus aureus) /MRSA (methicillin-resistant
           Staphylococcus aureus) nasal colonization status (standard preoperative evaluation)

        8. tobacco use history

        9. history of DVT (deep vein thrombosis) or PE (pulmonary embolism)

       10. other injuries associated with current trauma to calculate Injury Severity Score

      Patients will be treated with operative fixation of their fracture per standard of care.
      Within 24 hours of providing informed consent, we will obtain patient weight with a clinical
      scale or hospital bed equipped with clinical scale. We will obtain body composition using a
      validated handheld ultrasound device that reports fat mass, fat free mass, and % body fat
      (BodyMetrix, Intellimatrix, Brentwood, CA). Hand grip strength will be assessed with the
      patient's dominant hand, or non-dominant hand if unable to perform due to injury (hand
      dynamometer, Hausmann Industries, Northvale, New Jersey).

      Following surgery, patients in the treatment group will be asked to consume the nutritional
      supplement on a daily basis, in addition to standard nutrition. The control group will have
      standard nutrition provided per dietitian recommendation. Patients will have pain medication
      and postoperative therapies per standard of care.

      The nutritional supplements will be consumed per manufacturer recommendations. Descriptions
      of nutritional supplementation are included below.

      Juven is an oral nutritional supplement produced by Abbot Nutrition. It is not considered a
      drug and is not under FDA regulation. Juven has been studied in clinical trials and shown to
      decrease pressure ulcer occurrence, decrease muscle wasting, and increase collagen deposition
      in wound healing (10,11).

      Juven is packaged as a powder containing 24g per pouch and is mixed with 8-10 fl oz water or
      juice for consumption. The recommended supplementation schedule is two servings daily in
      addition to balanced diet.

      Nutrient data for Juven obtained from manufacturer's website 7/20/2017:
      https://abbottnutrition.com/juven Serving size: 24 g (1 packet) L-arginine 7g L-glutamine 7g
      Carbohydrate 7.9g Sugars 1g Calcium 200mg Calcium beta-hydroxy-beta-methylbutyrate 1.5g

      After discharge from the hospital, we will communicate with patients by mobile phone
      messaging on a daily basis to confirm consumption of the investigative nutritional
      supplementation. We will also communicate with patients at 3 months, 6 months, 9 months, and
      12 months after surgery to inquire about any complications or hospitalizations.

      Following surgery, patients will be reevaluated in the orthopedic trauma clinic at routine
      intervals per standard of care (postoperative visits are typically scheduled at 2 weeks, 6
      weeks, 6 months, and 1 year). Patients will be seen in clinic by orthopedic surgery trauma
      staff. All orthopedic trauma staff are included on the research team. As part of routine
      clinical follow up visit, research team will review the patient medical record, perform a
      focused history and physical exam and document any new hospital readmission, medical
      complication, surgical complication. Radiographs will be obtained per standard orthopedic
      care to assess fracture healing and no additional radiographs will be obtained for the
      purpose of this study.

      At the patient's first postoperative clinic follow up, we will repeat measures of patient
      weight, body composition, and hand grip strength. These measures are expected to take less
      than 15 minutes at the time of their clinic appointment.

      Subjects will also be asked to complete several questionnaires via RedCap at several times
      points during the study. The questionnaires will be completed either in clinic on a tablet or
      computer, or a secure link to the study will be emailed to subjects.

      No data collection is planned after one year from the time of surgery.
    

Intervention name(s): Juven
Intervention type(s): Dietary Supplement
Intervention description(s): Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention