Evaluation Perioperative Nutrition on Donor Site Healing in Patients Undergoing Reconstructive Burn Surg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539097
Recruitment Status : Terminated (change in donor site care protocol; donor site healing is a study endpoint)
First Posted : October 3, 2007
Last Update Posted : June 19, 2012
Information provided by (Responsible Party):
Theresa Mayes, Shriners Hospitals for Children

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).

Condition or disease Intervention/treatment Phase
Burn Reconstructive Surgical Procedure Dietary Supplement: Juven (Ross Products) protein supplement Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2005
Actual Primary Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A, treated
treated with Juven po supplement x 3 weeks postop
Dietary Supplement: Juven (Ross Products) protein supplement
Juven supplement oral x 3 weeks postop
No Intervention: B, control
Usual nutrition therapy received postop

Primary Outcome Measures :
  1. donor site healing time [ Time Frame: 3weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00539097

United States, Ohio
Shriners Hospital for Children
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Shriners Hospitals for Children
Principal Investigator: Theresa M Mayes, RD,LD Shriners Hospital for Children, Cincinnati, Ohio

Responsible Party: Theresa Mayes, Clinical Dietitian, Shriners Hospitals for Children Identifier: NCT00539097     History of Changes
Other Study ID Numbers: 03-04-23-05
First Posted: October 3, 2007    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Theresa Mayes, Shriners Hospitals for Children: