Burn WoundNCT04725071
Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
A study testing Impact Advanced Recovery and Boost High Protein in people with Burn Wound, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Burn Wound
- What is being tested?
- Impact Advanced Recovery and Boost High Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 9 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Burn Wound
- Being tested
- Impact Advanced Recovery, Boost High Protein
- Keywords
- immunonutrition
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact Advanced RecoveryDietary supplement
L-arginine and omega-3 rich supplement
Boost High ProteinDietary supplement
conventional supplement
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition | Experimental | Participants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay. Receives: Dietary Supplement: Impact Advanced Recovery |
| Conventional Supplement | Active comparator | Participants will consume a 6oz conventional supplement drink 3 times daily for 7 days and then once a day for remaining hospital stay. Receives: Dietary Supplement: Boost High Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Wound Closure
Measured: up to 3 months
Secondary outcomes (3)
Incidence of Surgical Grafting
Measured: up to 3 months
Length of Inpatient Stay
Measured: up to 3 months
Incidence of Infections
Infectious complications include pneumonia, urinary tract infection, wound infection, and blood stream infection.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Jul 2022
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn WoundStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca A Busch, MD, FACS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725071
- Sponsor's protocol ID
- 2020-1692
- Other IDs
- A539714, SMPH/SURGERY/TRAUMA, Protocol Version 1/14/2021
- Status last verified
- Nov 2024
- First submitted
- 21 Jan 2021
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults
- ClinicalTrials.gov ID
- NCT04725071
- Acronym / sponsor ID
- 2020-1692
- Conditions
- Burn Wound
- Keywords
- immunonutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition | Experimental | Dietary Supplement: Impact Advanced RecoveryParticipants will consume a 6oz immunonutrition drink 2 times daily for 7 days and then once a day for remaining hospital stay. |
| Conventional Supplement | Active comparator | Dietary Supplement: Boost High ProteinParticipants will consume a 6oz conventional supplement drink 3 times daily for 7 days and then once a day for remaining hospital stay. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact Advanced RecoveryL-arginine and omega-3 rich supplement | Dietary supplement | Immunonutrition |
| Boost High Proteinconventional supplement | Dietary supplement | Conventional Supplement |
Primary outcome
Time to Complete Wound Closure
Time frame: up to 3 months
3 secondary outcomes
Incidence of Surgical Grafting
Time frame: up to 3 months
Length of Inpatient Stay
Time frame: up to 3 months
Incidence of Infections
Time frame: up to 3 months
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca A Busch, MD, FACS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact Advanced Recovery and Boost High Protein in people with Burn Wound, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Wound Closure (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.