Use of Pressure Garments for Burn Scars

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

Official Title
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Prospective Randomized Study of the Effectiveness of Prospective Randomized Study on the Effectiveness of Pressure Garment Therapy for the Prevention of Hypertrophic Scarring in Burned Children

Conditions
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Burns

Intervention / Treatment
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* Device: Jobst Pressure Garment
* Device: Medical Z pressure garment


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pressure garment therapy | Device: Jobst Pressure Garment<br>* Pressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment.<br>* Other names: Pressure garments;Device: Medical Z pressure garment<br>* Pressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment.<br>* Other names: Jobst pressure garment;|
| No Intervention: 2<br>No pressure garment therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in scarring between pressure garment therapy and no pressure garment therapy |  | Time of burn to 2 years post burn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn, Scar, Pressure garments, Wound healing, Burn Injury