Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-09-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burn Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immunonutrition

Participants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay.

Group Type EXPERIMENTAL

Impact Advanced Recovery

Intervention Type DIETARY_SUPPLEMENT

L-arginine and omega-3 rich supplement

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.

Group Type ACTIVE_COMPARATOR

Boost High Protein

Intervention Type DIETARY_SUPPLEMENT

conventional supplement

Interventions

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Impact Advanced Recovery

L-arginine and omega-3 rich supplement

Intervention Type DIETARY_SUPPLEMENT

Boost High Protein

conventional supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No