Evaluation Perioperative Nutrition on Donor Site Healing... | NCT00539097

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

NCT00539097

Sponsor

Shriners Hospitals for Children

Status

Terminated

Last Update Posted

Jun 19, 2012Estimated

Enrollment

38Actual

Phase

Phase 2Phase 3

Conditions

Burn
Reconstructive Surgical Procedure

Interventions

Juven (Ross Products) protein supplement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

change in donor site care protocol; donor site healing is a study endpoint

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Oct 2007Actual

Completion Date

Not provided

First Submitted Date

Oct 1, 2007

First Submission Date that Met QC Criteria

Oct 1, 2007

First Posted Date

Oct 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2012

Last Update Posted Date

Jun 19, 2012Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Juven (Ross Products) protein supplement	Dietary Supplement	Juven supplement oral x 3 weeks postop	A, treated

Measure	Description	Time Frame
donor site healing time		3weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

24 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theresa M Mayes, RD,LD	Shriners Hospital for Children, Cincinnati, Ohio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shriners Hospital for Children		Cincinnati	Ohio	45229	United States