NCT00539097

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2007

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

October 1, 2007

Last Update Submit

June 18, 2012

Conditions

BurnReconstructive Surgical Procedure

Keywords

pediatrics

Outcome Measures

Primary Outcomes (1)

  • donor site healing time

    3weeks

Study Arms (2)

A, treated

EXPERIMENTAL

treated with Juven po supplement x 3 weeks postop

Dietary Supplement: Juven (Ross Products) protein supplement

B, control

NO INTERVENTION

Usual nutrition therapy received postop

Interventions

Juven (Ross Products) protein supplementDIETARY_SUPPLEMENT

Juven supplement oral x 3 weeks postop

A, treated

Eligibility Criteria

Age6 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospital for Children

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Theresa M Mayes, RD,LD

    Shriners Hospital for Children, Cincinnati, Ohio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Dietitian

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 3, 2007

Study Start

June 1, 2005

Primary Completion

October 1, 2007

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

US(1)