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

June 18, 2012 updated by: Theresa Mayes, Shriners Hospitals for Children
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Shriners Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
donor site healing time
Time Frame: 3weeks
3weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shriners Hospitals for Children

Investigators

  • Principal Investigator: Theresa M Mayes, RD,LD, Shriners Hospital for Children, Cincinnati, Ohio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 1, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (Estimate)

October 3, 2007

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-04-23-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burn

Clinical Trials on Juven (Ross Products) protein supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe