Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

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.

Study Overview

• Status: Terminated
• Conditions: Burn Wound
• Intervention / Treatment: Dietary supplement: Impact Advanced Recovery; Dietary supplement: Boost High Protein

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject has partial of full thickness thermal injury of 1-15% 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunonutrition; 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; L-arginine and omega-3 rich supplement
Active Comparator: Conventional Supplement; 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; conventional supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Rebecca A Busch, MD, FACS, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): September 9, 2024

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: immunonutrition
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 2020-1692; A539714 (Other Identifier: UW Madison); SMPH/SURGERY/TRAUMA (Other Identifier: UW Madison); Protocol Version 1/14/2021 (Other Identifier: UW Madison)

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
• product manufactured in and exported from the U.S.: No