Hypertrophic Scarring After Burn Injury
Conditions
Keywords
hypertrophic, scar, burn, cicatrix, pressure, garment
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.
Interventions
DEVICECustom fabricated pressure garments
Cloth garments designed to apply 17-24 mmHg pressure to the 1/2 the burn wound and \<5 mmHg to the other half, to be worn 23 hours per day until wounds mature, approximately 12 months
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure Under Compression Garment | Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5) | Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ''dose'' was measured directly. Values reported are averaged over indicated visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durometer (Hardness) of Wound | Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5) | A single Rex Durometer Hand Model 1600, Type 00, without a foot attachment (Rex Gauge Company Inc., Glenview, IL) was used to measure scar hardness throughout the study. This device measures hardness of light foams, sponge rubber gels, and animal tissue in durometer units (range 0=soft, 100=hard). Measurements were obtained with the person in the sitting position with the forearm supported in a horizontal position on a desk and the shoulder adducted. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm. |
| Color of Wound | Approximately12 months (follow-up visits 5) | A Chromameter Minolta CR-300 (Konica Minolta, Ramsey, NJ) measured skin color. Skin surface illuminated by pulsed xenon arc lamp. Light reflected perpendicular to surface collected for a tri-stimulus color analysis. One measurement consisted of three flashes of illumination in order to obtain a mean value. Measurement values are in the L\*a\*b\* color space was described by The Commission Internationale de I'Eclairage (CIE)(L=brightness \[100=white,0=black\], a=red-green\[red=60,green=-60\], b=yellow-blue\[yellow=60,blue=-60\]) |
| Thickness of Wound | Approximately 12 months (follow-up visit 5) | Scar thickness in millimeters was obtained with high-frequency ultrasonography in the Department of Radiology. Several machines and probes were used over the years each with accuracy to 0.5 mm. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm. |
| Clinical Appearance of Wound | Approximately 12 months (follow-up visit 5) | Photographs of wounds showed final cosmetic result. The two compression areas for each photograph were labeled distal (D) and proximal (P). We asked 11 experts (blinded as to the compression of the rated zones) to judge which zone (D or P) had the better cosmetic appearance or whether there was no difference. Votes were tallied according to the unblinded compression zone (i.e., high/normal and low). We report number of participants for which the rating experts all agreed or did not all agree (i.e., voted the other zone or no difference) that the indicated zone had the better appearance. |
| Compliance With Wearing Compression Garment | About 12 months (follow-up visit 5) | The patients were asked to complete a compliance form indicating how many hours the garment was worn each day. |
Countries
United States
Participant flow
Recruitment details
During the 12-year period from 1995 to 2007, in accord with the Human Subjects Division of the University of Washington, 67 consecutive patients were enrolled. Thirteen patients exited the study prior to any data collection. Eleven of these chose to remove themselves, one was lost to follow-up and the reason was not recorded for one patient.
Participants by arm
| Arm | Count |
|---|---|
| Pressure Garment on Burn Wound Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17-24 mm Hg to the normal/high compression zone and \<5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 10 |
Baseline characteristics
| Characteristic | Pressure Garment on Burn Wound |
|---|---|
| Age Continuous | 36 years STANDARD_DEVIATION 14 |
| Age, Customized 15-30 years | 17 participants |
| Age, Customized 31-59 years | 34 participants |
| Age, Customized 7-14 years | 3 participants |
| Region of Enrollment United States | 54 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Pressure Under Compression Garment
Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ''dose'' was measured directly. Values reported are averaged over indicated visits.
Time frame: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Population: All Participants with available and evaluable measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal/High Pressure Zone | Pressure Under Compression Garment | 25 mm Hg | Standard Deviation 6.3 |
| Low Compression Zone | Pressure Under Compression Garment | 6.4 mm Hg | Standard Deviation 6.2 |
Secondary
Clinical Appearance of Wound
Photographs of wounds showed final cosmetic result. The two compression areas for each photograph were labeled distal (D) and proximal (P). We asked 11 experts (blinded as to the compression of the rated zones) to judge which zone (D or P) had the better cosmetic appearance or whether there was no difference. Votes were tallied according to the unblinded compression zone (i.e., high/normal and low). We report number of participants for which the rating experts all agreed or did not all agree (i.e., voted the other zone or no difference) that the indicated zone had the better appearance.
Time frame: Approximately 12 months (follow-up visit 5)
Population: All Participants with available and evaluable measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Normal/High Pressure Zone | Clinical Appearance of Wound | All experts agree zone has better appearance | 3 Participants |
| Normal/High Pressure Zone | Clinical Appearance of Wound | All experts do not agree zone has better appearanc | 38 Participants |
| Low Compression Zone | Clinical Appearance of Wound | All experts agree zone has better appearance | 0 Participants |
| Low Compression Zone | Clinical Appearance of Wound | All experts do not agree zone has better appearanc | 41 Participants |
Secondary
Color of Wound
A Chromameter Minolta CR-300 (Konica Minolta, Ramsey, NJ) measured skin color. Skin surface illuminated by pulsed xenon arc lamp. Light reflected perpendicular to surface collected for a tri-stimulus color analysis. One measurement consisted of three flashes of illumination in order to obtain a mean value. Measurement values are in the L\*a\*b\* color space was described by The Commission Internationale de I'Eclairage (CIE)(L=brightness \[100=white,0=black\], a=red-green\[red=60,green=-60\], b=yellow-blue\[yellow=60,blue=-60\])
Time frame: Approximately12 months (follow-up visits 5)
Population: All Participants with available and evaluable measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal/High Pressure Zone | Color of Wound | L color parameter | 56.3 color space parameter units | Standard Deviation 18.6 |
| Normal/High Pressure Zone | Color of Wound | a color parameter | 9 color space parameter units | Standard Deviation 9.7 |
| Normal/High Pressure Zone | Color of Wound | b color parameter | 8.2 color space parameter units | Standard Deviation 3.2 |
| Low Compression Zone | Color of Wound | L color parameter | 55.2 color space parameter units | Standard Deviation 17.6 |
| Low Compression Zone | Color of Wound | a color parameter | 9.5 color space parameter units | Standard Deviation 9.2 |
| Low Compression Zone | Color of Wound | b color parameter | 8.5 color space parameter units | Standard Deviation 3.2 |
Secondary
Compliance With Wearing Compression Garment
The patients were asked to complete a compliance form indicating how many hours the garment was worn each day.
Time frame: About 12 months (follow-up visit 5)
Population: All Participants with available and evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal/High Pressure Zone | Compliance With Wearing Compression Garment | 20.4 hours per day | Standard Deviation 3.9 |
Secondary
Durometer (Hardness) of Wound
A single Rex Durometer Hand Model 1600, Type 00, without a foot attachment (Rex Gauge Company Inc., Glenview, IL) was used to measure scar hardness throughout the study. This device measures hardness of light foams, sponge rubber gels, and animal tissue in durometer units (range 0=soft, 100=hard). Measurements were obtained with the person in the sitting position with the forearm supported in a horizontal position on a desk and the shoulder adducted. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm.
Time frame: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Population: All Participants with available and evaluable measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal/High Pressure Zone | Durometer (Hardness) of Wound | Study Period 4 (n=33) | 45 durometer units | Standard Deviation 7 |
| Normal/High Pressure Zone | Durometer (Hardness) of Wound | Study Period 2 (n=44) | 46 durometer units | Standard Deviation 8 |
| Normal/High Pressure Zone | Durometer (Hardness) of Wound | Study Period 5 (n=26) | 45 durometer units | Standard Deviation 7 |
| Normal/High Pressure Zone | Durometer (Hardness) of Wound | Study Period 3 (n=37) | 47 durometer units | Standard Deviation 7 |
| Normal/High Pressure Zone | Durometer (Hardness) of Wound | Study Period 1 (n=51) | 47 durometer units | Standard Deviation 7 |
| Low Compression Zone | Durometer (Hardness) of Wound | Study Period 3 (n=37) | 48 durometer units | Standard Deviation 8 |
| Low Compression Zone | Durometer (Hardness) of Wound | Study Period 4 (n=33) | 48 durometer units | Standard Deviation 7 |
| Low Compression Zone | Durometer (Hardness) of Wound | Study Period 5 (n=26) | 49 durometer units | Standard Deviation 7 |
| Low Compression Zone | Durometer (Hardness) of Wound | Study Period 2 (n=44) | 49 durometer units | Standard Deviation 7 |
| Low Compression Zone | Durometer (Hardness) of Wound | Study Period 1 (n=51) | 46 durometer units | Standard Deviation 6 |
| Kneecap | Durometer (Hardness) of Wound | Study Period 3 (n=37) | NA durometer units | — |
| Kneecap | Durometer (Hardness) of Wound | Study Period 1 (n=51) | 72 durometer units | Standard Deviation 9 |
| Kneecap | Durometer (Hardness) of Wound | Study Period 2 (n=44) | NA durometer units | — |
| Kneecap | Durometer (Hardness) of Wound | Study Period 4 (n=33) | NA durometer units | — |
| Kneecap | Durometer (Hardness) of Wound | Study Period 5 (n=26) | NA durometer units | — |
| Uninjured Forearm Skin | Durometer (Hardness) of Wound | Study Period 4 (n=33) | NA durometer units | — |
| Uninjured Forearm Skin | Durometer (Hardness) of Wound | Study Period 2 (n=44) | NA durometer units | — |
| Uninjured Forearm Skin | Durometer (Hardness) of Wound | Study Period 1 (n=51) | 39 durometer units | Standard Deviation 4 |
| Uninjured Forearm Skin | Durometer (Hardness) of Wound | Study Period 3 (n=37) | NA durometer units | — |
| Uninjured Forearm Skin | Durometer (Hardness) of Wound | Study Period 5 (n=26) | NA durometer units | — |
Secondary
Thickness of Wound
Scar thickness in millimeters was obtained with high-frequency ultrasonography in the Department of Radiology. Several machines and probes were used over the years each with accuracy to 0.5 mm. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm.
Time frame: Approximately 12 months (follow-up visit 5)
Population: All Participants with available and evaluable measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal/High Pressure Zone | Thickness of Wound | 2.8 mm | Standard Deviation 3.2 |
| Low Compression Zone | Thickness of Wound | 3.4 mm | Standard Deviation 3 |