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

NCT ID: NCT00539097

Last Updated: 2012-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Burn Reconstructive Surgical Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A, treated

treated with Juven po supplement x 3 weeks postop

Group Type EXPERIMENTAL

Juven (Ross Products) protein supplement

Intervention Type DIETARY_SUPPLEMENT

Juven supplement oral x 3 weeks postop

B, control

Usual nutrition therapy received postop

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Juven (Ross Products) protein supplement

Juven supplement oral x 3 weeks postop

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role lead

Responsible Party

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Theresa Mayes

Clinical Dietitian

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theresa M Mayes, RD,LD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospital for Children, Cincinnati, Ohio

Locations

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Shriners Hospital for Children

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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03-04-23-05

Identifier Type: -

Identifier Source: org_study_id

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