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Use of Pressure Garments for Burn Scars

NCT ID: NCT00675974

Last Updated: 2012-11-15

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

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2014-12-31

Brief Summary

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1. Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure Garment Therapy.
2. How will Pressure Garment Therapy affect functional capacity or scar contracture development across joints either in number or severity.
3. Will Pressure Garment Therapy diminish discomfort due to pruritus.

Detailed Description

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Conditions

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Burns

Keywords

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Burn Scar Pressure garments Wound healing Burn Injury

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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1

Pressure garment therapy

Group Type EXPERIMENTAL

Jobst Pressure Garment

Intervention Type DEVICE

Pressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment.

Medical Z pressure garment

Intervention Type DEVICE

Pressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment.

2

No pressure garment therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Jobst Pressure Garment

Pressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment.

Intervention Type DEVICE

Medical Z pressure garment

Pressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment.

Intervention Type DEVICE

Other Intervention Names

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Jobst pressure garments Medical Z pressure garments Pressure garments Pressure garment Jobst pressure garment

Eligibility Criteria

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Inclusion Criteria

* At least 30% total body surface area(TBSA) second degree burns or at least 10% TBSA full-thickness burns including bilateral comparable burns to upper and/or lower extremities.
* at least 1 year of age and no more than 17 years of age
* Wound closure
* No evidence of deep venous thrombosis or other vascular compromise.
* No concomitant conflicting study protocols.

Exclusion Criteria

* Burn injuries not bilateral to upper and/or lower extremities.
* Evidence of vascular compromise.
* Conflicting protocols.
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Department of Education

FED

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David N Herndon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Countries

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United States

Other Identifiers

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NIDRR

Identifier Type: -

Identifier Source: secondary_id

05-126

Identifier Type: -

Identifier Source: org_study_id