NCT00539097TerminatedPhase 2
Evaluation Perioperative Nutrition on Donor Site Healing in Patients Undergoing Reconstructive Burn Surg
Shriners Hospitals for Children1 site in 1 country38 target enrollmentStarted: June 1, 2005Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- donor site healing time
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 24 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
A, treated
Experimental
treated with Juven po supplement x 3 weeks postop
Intervention: Juven (Ross Products) protein supplement (Dietary Supplement)
B, control
No Intervention
Usual nutrition therapy received postop
Outcomes
Primary Outcomes
donor site healing time
Time Frame: 3weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Theresa Mayes
Clinical Dietitian
Shriners Hospitals for Children
Study Sites (1)
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