An interventional study of Impact Advanced Recovery and Boost High Protein in Burn Wound, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 11 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
L-arginine and omega-3 rich supplement
conventional supplement
Time to Complete Wound Closure
Time frame: up to 3 months
Incidence of Surgical Grafting
Time frame: up to 3 months
Length of Inpatient Stay
Time frame: up to 3 months
Incidence of Infections
Infectious complications include pneumonia, urinary tract infection, wound infection, and blood stream infection.
Time frame: up to 3 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison