Clinical trial NCT01005732: Effectiveness of Pressure Garment Therapy After Burns
Official title: Effectiveness of Pressure Garment Therapy After Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Scarring After Burn Injury
Keywords: hypertrophic
scar
burn
cicatrix
pressure
garment
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 67
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the prevention of hypertrophic scarring in healed burns.

Background - Approximately one million people are burned each year in the United States. The most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that interferes with work and all other aspects of life. Pressure garment therapy is routinely used to minimize hypertrophic scarring even though there is no scientifically valid data that this therapy is efficacious. Pressure garments are extremely unattractive, expensive and uncomfortable and their use needs to be based upon valid data.

Goals and Objectives - The investigators plan to determine the effectiveness of pressure garment therapy in the control of hypertrophic scarring in healed burns.

Methods - The I-Scan® device was designed to measure pressure at the body/environment interface and allows clinicians to deal with pressure-related problems for at-risk patients. It has been widely used in rehabilitation medicine but not with burn survivors. The investigators will use this device to measure the pressure at the garment/skin interface. 2) Furthermore, the few studies that have been attempted to determine efficacy have used between subjects designs. Since burn depth is extremely variable from patient to patient and since hypertrophic scarring is greatly influenced by age and race/origin, the between subjects design requires very large numbers of subjects. The investigators will use a within wounds design studying forearm burns and applying pressure to half of the wound and no pressure to the other half. The investigators will then compare hardness, color, thickness and clinical appearance.


Eligibility criteria: Inclusion Criteria:

* Treated from time of burn at the University of Washington Burn Center during the first two years of the grant period
* Burns covering the majority of the forearm that healed spontaneously in three or more weeks. Patients will be entered into the study within 4 weeks of injury.
* Age 7-65 years. Patients younger than 7 years will be excluded given the cooperation required during follow-up evaluations. Patients over 65 years will be excluded since the incidence of hypertrophic scarring in persons over 65 is too low to warrant pressure garment trials.
* Patients of any race, ethnicity, or skin color.
* Informed, written consent in accord with the rules of the Human Subjects Committee of the University of Washington and the Health Insurance Portability and Accountability Act (HIPAA).

Exclusion Criteria:

* Incarcerated patients
* Homeless patients
* Patients with substance abuse
* Patients with psychiatric diagnosis
* Patients unavailable to return regularly for follow-up evaluations

Primary outcomes:
measure: Pressure Under Compression Garment
timeFrame: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Secondary outcomes:
measure: Durometer (Hardness) of Wound
timeFrame: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
measure: Color of Wound
timeFrame: Approximately12 months (follow-up visits 5)
measure: Thickness of Wound
timeFrame: Approximately 12 months (follow-up visit 5)
measure: Clinical Appearance of Wound
timeFrame: Approximately 12 months (follow-up visit 5)
measure: Compliance With Wearing Compression Garment
timeFrame: About 12 months (follow-up visit 5)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Burn Center
state: Washington
Study officials:
affiliation: University of Washington
name: Loren Engrav
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engrav LH, Heimbach DM, Rivara FP, Moore ML, Wang J, Carrougher GJ, Costa B, Numhom S, Calderon J, Gibran NS. 12-Year within-wound study of the effectiveness of custom pressure garment therapy. Burns. 2010 Nov;36(7):975-83. doi: 10.1016/j.burns.2010.04.014. Epub 2010 Jul 1.