Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

Burn Wound Clinical Trial

Official title:

Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04725071
• Other study ID #: 2020-1692
• Secondary ID: A539714SMPH/SURG
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burn Wound
• Burns
• Wounds and Injuries

Intervention

Dietary Supplement:
• Impact Advanced Recovery
L-arginine and omega-3 rich supplement
• Boost High Protein
conventional supplement

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Complete Wound Closure		up to 3 months
Secondary	Incidence of Surgical Grafting		up to 3 months
Secondary	Length of Inpatient Stay		up to 3 months
Secondary	Incidence of Infections	Infectious complications include pneumonia, urinary tract infection, wound infection, and blood stream infection.	up to 3 months