Use of Pressure Garments for Burn Scars

NCT00675974 | Withdrawn Phase 2 DMC

• 2 other identifiers: 05-126NIDRR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Burns

Keywords

Burn; Scar; Pressure garments; Wound healing; Burn Injury

Outcome Measures

Primary Outcomes (1)

• Differences in scarring between pressure garment therapy and no pressure garment therapy

  Time of burn to 2 years post burn

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Pressure garment therapy

Device: Jobst Pressure Garment; Device: Medical Z pressure garment

2

NO INTERVENTION

No pressure garment therapy

Interventions

Jobst Pressure Garment DEVICE

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

Also known as: Jobst pressure garments, Medical Z pressure garments, Pressure garments

1

Medical Z pressure garment DEVICE

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

Also known as: Pressure garment, Jobst pressure garment

1

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Burn injuries not bilateral to upper and/or lower extremities.
• Evidence of vascular compromise.
• Conflicting protocols.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• U.S. Department of Education: collaborator

MeSH Terms

Conditions

Burns; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David N Herndon, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: May 12, 2008
• Study Start: August 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: November 15, 2012

Record last verified: 2012-11