Use of Pressure Garments for Burn Scars

Phase 2

Withdrawn

• Conditions: Burns
• Interventions: Device: Jobst Pressure Garment; Device: Medical Z pressure garment

• Registration Number: NCT00675974
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

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

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-15
• Primary Completion: 2012-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Jobst Pressure Garment	Pressure garment therapy
1	Medical Z pressure garment	Pressure garment therapy

Primary Outcome Measures

Name	Time	Method
Differences in scarring between pressure garment therapy and no pressure garment therapy	Time of burn to 2 years post burn

Secondary Outcome Measures

Name	Time	Method
Effect of Pressure Garment Therapy on functional capacity or scar contracture development across joints either in number or severity compared to no pressure garment therapy.	Time of burn to 2 years post burn
Effect of pressure garment therapy on scar discomfort and pruritis compared to no pressure garment therapy	Time of burn to 2 years post burn