Use of Pressure Garments for Burn Scars

Burns Clinical Trial

— Jobst  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00675974
• Other study ID #: 05-126
• Secondary ID: NIDRR
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: December 26, 2007
• Last updated: November 13, 2012
• Start date: August 2005
• Est. completion date: December 2014

Study information

• Verified date: November 2012
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Jobst Pressure Garment
Pressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment.
• Medical Z pressure garment
Pressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	U.S. Department of Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in scarring between pressure garment therapy and no pressure garment therapy		Time of burn to 2 years post burn	No
Secondary	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	No
Secondary	Effect of pressure garment therapy on scar discomfort and pruritis compared to no pressure garment therapy		Time of burn to 2 years post burn	No