Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

Phase

N/A

Condition

Hyponatremia

Skin Wounds

Treatment

Boost High Protein

Impact Advanced Recovery

Clinical Study ID

NCT04725071

2020-1692

A539714

Protocol Version 1/14/2021

SMPH/SURGERY/TRAUMA

Ages > 55
All Genders

Study Summary

This pilot study aims to assess the feasibility of providing immunonutrition supplementation to older burn patients (age 55 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subject has partial of full thickness thermal injury of 1-15% of total body surfacearea (TBSA)
Subject has an inpatient admission for their burn
Subject or authorized decision maker understands the study procedures and canprovide informed consent to participate in the study and authorization for releaseof relevant protected health information to the study investigator

Exclusion

Exclusion Criteria:

Subject with inhalation injury and/or intubation
Subject receiving immunosuppressive medications including chronic steroids, immunemodulating medications, and chemotherapy prior to admission
Subject with pre-existing severe chronic liver disease or end stage renal disease

Study Design

Boost High Protein

July 01, 2022

September 09, 2024

Study Description

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 55 years with 1-15% 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.

Connect with a study center

University of Wisconsin
Madison, Wisconsin 53792
United States
Site Not Available

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