Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
Primary Purpose
Burn Wound
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Impact Advanced Recovery
Boost High Protein
Sponsored by
About this trial
This is an interventional treatment trial for Burn Wound focused on measuring immunonutrition
Eligibility Criteria
Inclusion Criteria:
- Subject has partial of full thickness thermal injury of 5-15% 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
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immunonutrition
Conventional Supplement
Arm Description
Participants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay.
Participants will consume a 6oz conventional supplement drink 3 times daily for 7 days and then once a day for remaining hospital stay.
Outcomes
Primary Outcome Measures
Time to Complete Wound Closure
Secondary Outcome Measures
Incidence of Surgical Grafting
Length of Inpatient Stay
Incidence of Infections
Infectious complications include pneumonia, urinary tract infection, wound infection, and blood stream infection.
Full Information
NCT ID
NCT04725071
First Posted
January 21, 2021
Last Updated
January 25, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04725071
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This pilot study aims to assess the feasibility of providing immunonutrition supplementation to older burn patients (age 65 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 65 years with 5-15% 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wound
Keywords
immunonutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immunonutrition
Arm Type
Experimental
Arm Description
Participants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay.
Arm Title
Conventional Supplement
Arm Type
Active Comparator
Arm Description
Participants will consume a 6oz conventional supplement drink 3 times daily for 7 days and then once a day for remaining hospital stay.
Intervention Type
Dietary Supplement
Intervention Name(s)
Impact Advanced Recovery
Intervention Description
L-arginine and omega-3 rich supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Boost High Protein
Intervention Description
conventional supplement
Primary Outcome Measure Information:
Title
Time to Complete Wound Closure
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Incidence of Surgical Grafting
Time Frame
up to 3 months
Title
Length of Inpatient Stay
Time Frame
up to 3 months
Title
Incidence of Infections
Description
Infectious complications include pneumonia, urinary tract infection, wound infection, and blood stream infection.
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has partial of full thickness thermal injury of 5-15% 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca A Busch, MD, FACS
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
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