BurnPhase 2/3NCT00539097
Evaluation Perioperative Nutrition on Donor Site Healing in Patients Undergoing Reconstructive Burn Surg
A Phase 2/3 study testing Juven (Ross Products) protein supplement in people with Burn and Reconstructive Surgical Procedure, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
The investigators hope to learn if taking a nutrition drink for a short time after surgery for an elective reconstructive burn injury improves donor site healing, muscle mass and scar maturation time (the point at which the redness, height and firmness of the wound has faded, flattened and softened, and no longer… Read more about this study
- Who is it for?
- Ages 6 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn, Reconstructive Surgical Procedure
- What is being tested?
- Juven (Ross Products) protein supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Oct 2007
- Phase
- Phase 2/3
- 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 6 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- At least one year post-acute burn injury
- Admitted for surgery whereby split thickness donor site created
- Received initial acute treatment at Shriner's Hospital in Cincinnati
Who cannot join
- Less than 6years of age
- Less than one year from acute burn injury
- Split thickness donor site/autograft not anticipated
- Initial treatment not at Shriners Hospital in Cincinnati
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Cincinnati, Ohio, 45229
About this study
The investigators hope to learn if taking a nutrition drink for a short time after surgery for an elective reconstructive burn injury improves donor site healing, muscle mass and scar maturation time (the point at which the redness, height and firmness of the wound has faded, flattened and softened, and no longer changes in appearance).
- Conditions
- Burn, Reconstructive Surgical Procedure
- Being tested
- Juven (Ross Products) protein supplement
- Keywords
- pediatrics
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juven (Ross Products) protein supplementDietary supplement
Juven supplement oral x 3 weeks postop
| Study group | Role | What they receive |
|---|---|---|
| A, treated | Experimental | treated with Juven po supplement x 3 weeks postop Receives: Dietary Supplement: Juven (Ross Products) protein supplement |
| B, control | No intervention | Usual nutrition therapy received postop |
What is being measured
The primary outcome is the main question the study is designed to answer.
donor site healing time
Measured: 3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startJun 2005
- Primary completionOct 2007
Why it stopped: change in donor site care protocol; donor site healing is a study endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Mayes, Shriners Hospitals for Children
- Investigators
- Theresa M Mayes, RD,LD, Principal investigator, Shriners Hospital for Children, Cincinnati, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539097
- Sponsor's protocol ID
- 03-04-23-05
- Status last verified
- Jun 2012
- First submitted
- 1 Oct 2007
- Last updated
- 19 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Perioperative Nutrition on Donor Site Healing in Patients Undergoing Reconstructive Burn Surg
- ClinicalTrials.gov ID
- NCT00539097
- Acronym / sponsor ID
- 03-04-23-05
- Conditions
- Burn, Reconstructive Surgical Procedure
- Keywords
- pediatrics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in donor site care protocol; donor site healing is a study endpoint
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Oct 2007 (actual)
- First posted
- 3 Oct 2007 (estimated)
- 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.
The investigators hope to learn if taking a nutrition drink for a short time after surgery for an elective reconstructive burn injury improves donor site healing, muscle mass and scar maturation time (the point at which the redness, height and firmness of the wound has faded, flattened and softened, and no longer changes in appearance).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, treated | Experimental | Dietary Supplement: Juven (Ross Products) protein supplementtreated with Juven po supplement x 3 weeks postop |
| B, control | No intervention | –Usual nutrition therapy received postop |
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- At least one year post-acute burn injury
- Admitted for surgery whereby split thickness donor site created
- Received initial acute treatment at Shriner's Hospital in Cincinnati
Key exclusion criteria (4 listed)
- Less than 6years of age
- Less than one year from acute burn injury
- Split thickness donor site/autograft not anticipated
- Initial treatment not at Shriners Hospital in Cincinnati
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 |
|---|---|---|
| Juven (Ross Products) protein supplementJuven supplement oral x 3 weeks postop | Dietary supplement | A, treated |
Primary outcome
donor site healing time
Time frame: 3weeks
Results and safety
The study was stopped early (reason given: change in donor site care protocol; donor site healing is a study endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
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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.
Theresa M Mayes, RD,LD principal investigator
Shriners Hospital for Children, Cincinnati, Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Juven (Ross Products) protein supplement in people with Burn and Reconstructive Surgical Procedure, run by Shriners Hospitals for Children 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 4 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 19 Jun 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: change in donor site care protocol; donor site healing is a study endpoint). 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?
donor site healing time (time frame: 3weeks). 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 19 Jun 2012.