Back to resultsEvaluation Perioperative Nutrition on Donor Site Healing in Patients Undergoing Reconstructive Burn Surg
Primary Purpose
Burn, Reconstructive Surgical Procedure
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Juven (Ross Products) protein supplement
Sponsored by
About this trial
This is an interventional treatment trial for Burn focused on measuring pediatrics
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Shriners Hospital for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A, treated
B, control
Arm Description
treated with Juven po supplement x 3 weeks postop
Usual nutrition therapy received postop
Outcomes
Primary Outcome Measures
donor site healing time
Secondary Outcome Measures
Full Information
NCT ID
NCT00539097
First Posted
October 1, 2007
Last Updated
June 18, 2012
Sponsor
Shriners Hospitals for Children
1. Study Identification
Unique Protocol Identification Number
NCT00539097
Brief Title
Evaluation Perioperative Nutrition on Donor Site Healing in Patients Undergoing Reconstructive Burn Surg
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
change in donor site care protocol; donor site healing is a study endpoint
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children
4. Oversight
5. Study Description
Brief 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 changes in appearance).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn, Reconstructive Surgical Procedure
Keywords
pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A, treated
Arm Type
Experimental
Arm Description
treated with Juven po supplement x 3 weeks postop
Arm Title
B, control
Arm Type
No Intervention
Arm Description
Usual nutrition therapy received postop
Intervention Type
Dietary Supplement
Intervention Name(s)
Juven (Ross Products) protein supplement
Intervention Description
Juven supplement oral x 3 weeks postop
Primary Outcome Measure Information:
Title
donor site healing time
Time Frame
3weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa M Mayes, RD,LD
Organizational Affiliation
Shriners Hospital for Children, Cincinnati, Ohio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospital for Children
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation Perioperative Nutrition on Donor Site Healing in Patients Undergoing Reconstructive Burn Surg
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