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Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Terminated

Conditions

Burn Wound

Treatments

Dietary Supplement: Impact Advanced Recovery
Dietary Supplement: Boost High Protein

Study type

Interventional

Funder types

Other

Identifiers

NCT04725071
A539714 (Other Identifier)
2020-1692
SMPH/SURGERY/TRAUMA (Other Identifier)
Protocol Version 1/14/2021 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

11 participants in 2 patient groups

Immunonutrition
Experimental group
Description:
Participants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay.
Treatment:
Dietary Supplement: Impact Advanced Recovery
Conventional Supplement
Active Comparator group
Description:
Participants will consume a 6oz conventional supplement drink 3 times daily for 7 days and then once a day for remaining hospital stay.
Treatment:
Dietary Supplement: Boost High Protein

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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