Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

NCT04725071 | Terminated

• 4 other identifiers: 2020-1692A539714SMPH/SURGERY/TRAUMAProtocol Version 1/14/2021
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Wound

Keywords

immunonutrition

Outcome Measures

Primary Outcomes (1)

• Time to Complete Wound Closure

  up to 3 months

Secondary Outcomes (3)

• Incidence of Surgical Grafting

  up to 3 months

• Length of Inpatient Stay

  up to 3 months

• Incidence of Infections

  up to 3 months

Study Arms (2)

Immunonutrition

EXPERIMENTAL

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

Conventional Supplement

ACTIVE COMPARATOR

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

Interventions

Impact Advanced Recovery DIETARY_SUPPLEMENT

L-arginine and omega-3 rich supplement

Immunonutrition

Boost High Protein DIETARY_SUPPLEMENT

conventional supplement

Conventional Supplement

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Rebecca A Busch, MD, FACS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: July 1, 2022
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)