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

This study has been terminated.
(change in donor site care protocol; donor site healing is a study endpoint)
Sponsor:
Information provided by (Responsible Party):
Theresa Mayes, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00539097
First received: October 1, 2007
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Burn
Reconstructive Surgical Procedure
Dietary Supplement: Juven (Ross Products) protein supplement
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • donor site healing time [ Time Frame: 3weeks ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: June 2005
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539097

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

No publications provided

Responsible Party: Theresa Mayes, Clinical Dietitian, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00539097     History of Changes
Other Study ID Numbers: 03-04-23-05
Study First Received: October 1, 2007
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
pediatrics

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 22, 2014