Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

Not Applicable

Terminated

• Conditions: Burn Wound
• Interventions: Dietary Supplement: Impact Advanced Recovery; Dietary Supplement: Boost High Protein

• Registration Number: NCT04725071
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

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 Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Study Start: 2022-07-01
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunonutrition	Impact Advanced Recovery	Participants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay.
Conventional Supplement	Boost High Protein	Participants will consume a 6oz conventional supplement drink 3 times daily for 7 days and then once a day for remaining hospital stay.

Primary Outcome Measures

Name	Time	Method
Time to Complete Wound Closure	up to 3 months

Secondary Outcome Measures

Name	Time	Method
Length of Inpatient Stay	up to 3 months
Incidence of Surgical Grafting	up to 3 months
Incidence of Infections	up to 3 months	Infectious complications include pneumonia, urinary tract infection, wound infection, and blood stream infection.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States