Trauma Screening and Supplementation

Improving Preoperative Screening and Postoperative Nutrition in Trauma Patients: Does it Decrease Muscle Wasting or Complications

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Wound Heal; Nutritional Deficiency
• Intervention / Treatment: Dietary supplement: Juven

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of acute fracture of the upper extremity, pelvis, or lower extremity with plans for operative fixation

Exclusion Criteria:

• Patients with comorbidities excluding the use of proposed nutritional supplement (phenylketonuria, galactoseria)
• Patients with major head trauma
• Pregnant women

Dementia

Vulnerable populations (minors, prisoners)

Lack of decision making capacity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional supplement group; Subjects in this group will be asked to consume the nutritional supplement on a daily basis, in addition to standard nutrition. Subjects will have pain medication and postoperative therapies per standard of care.	Dietary supplement: Juven; Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations
No Intervention: Standard nutrition group; Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body composition	Change in muscle mass	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hand grip strength	Change in hand grip strength as measured by hand held dynamometer	One year
Number of participants with post-operative complications	Medical and surgical complications following operative fracture fixation, validated patient reported outcome measures, radiographic measures of fracture healing, time spent in hospital, discharge status (home versus acute rehabilitation versus skilled nursing facility)	One year

Collaborators and Investigators

• Sponsor: Michael C Willey
• Collaborators: Orthopaedic Trauma Association
• Investigators: Principal Investigator: Nathan Hendrickson, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): November 13, 2019
• Study Completion (Actual): November 13, 2019

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Wounds and Injuries; Malnutrition
• Other Study ID Numbers: 201706789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No