Clinical trial NCT04725071: Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
Official title: Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burn Wound
Keywords: immunonutrition
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 11
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Complete Wound Closure
timeFrame: up to 3 months
Secondary outcomes:
measure: Incidence of Surgical Grafting
timeFrame: up to 3 months
measure: Length of Inpatient Stay
timeFrame: up to 3 months
measure: Incidence of Infections
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Rebecca A Busch, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: