Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

Study Overview
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Brief Summary
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This pilot study aims to assess the feasibility of providing immunonutrition supplementation to older burn patients (age 65 and older) and its impact on burn wound healing. Supplements containing arginine and omega 3 fatty acids have been shown to have beneficial effects on healing in other types of wounds but data within the burn population remains limited. 20 participants will be randomized into two arms, immunonutrition or conventional supplement and can expect to be on study for 3 months.

Detailed Description
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Studies performed previously in burn patients have had mixed patient cohorts with small sample sizes and these have failed to show any large improvements in wound healing. However, in older populations the investigators suspect that immunonutrition supplements may have a larger benefit to these patients as they often present with malnutrition and are more likely to struggle with delayed wound healing. In this pilot study, the investigators look to assess the impact of immunonutrition supplements the burn wound healing of adults over the age of 65 years with 5-15% total burn surface area (TBSA) partial thickness and full thickness burn injuries. The primary outcome objective of the study will be time to complete wound closure. The secondary objectives include need for surgical grafting, length of inpatient stay, and infections including pneumonia, urinary tract infections, wound infections, and blood stream infections.

Official Title
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Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

Conditions
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Burn Wound

Intervention / Treatment
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* Dietary Supplement: Impact Advanced Recovery
* Dietary Supplement: Boost High Protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has partial of full thickness thermal injury of 5-15% of total body surface area (TBSA) Subject has an inpatient admission for their burn Subject or authorized decision maker understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator Exclusion Criteria: Subject with inhalation injury and/or intubation Subject receiving immunosuppressive medications including chronic steroids, immune modulating medications, and chemotherapy prior to admission Subject with pre-existing severe chronic liver disease or end stage renal disease

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunonutrition<br>Participants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay. | Dietary Supplement: Impact Advanced Recovery<br>* L-arginine and omega-3 rich supplement<br>|
| Active Comparator: Conventional Supplement<br>Participants will consume a 6oz conventional supplement drink 3 times daily for 7 days and then once a day for remaining hospital stay. | Dietary Supplement: Boost High Protein<br>* conventional supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete Wound Closure |  | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Surgical Grafting |  | up to 3 months | 
| Length of Inpatient Stay |  | up to 3 months | 
| Incidence of Infections | Infectious complications include pneumonia, urinary tract infection, wound infection, and blood stream infection. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunonutrition