An interventional study of Custom fabricated pressure garments in Hypertrophic Scarring After Burn Injury, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 7 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-04-04.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
656 studies on the registry are indexed under Hypertrophy; 87 are open to participants now.
This study's enrollment of 67 is above the median of 50 across 460 interventional studies indexed under Hypertrophy.
Browse Hypertrophy studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
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
Also known as: Medical Z (Medical Z, San Antonio, TX)
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)
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)
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)
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)
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)
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)
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.
| Milestone | Pressure Garment on Burn Wound |
|---|---|
| Started | 54 |
| Completed | 43 |
| Not completed | 11 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Death | 1 |
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.
| mm Hg | Normal/High Pressure Zone | Low Compression Zone |
|---|---|---|
| Pressure Under Compression Garment | 25 ± 6.3 | 6.4 ± 6.2 |
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.
| durometer units | Normal/High Pressure Zone | Low Compression Zone | Kneecap | Uninjured Forearm Skin |
|---|---|---|---|---|
| Study Period 1 (n=51) | 47 ± 7 | 46 ± 6 | 72 ± 9 | 39 ± 4 |
| Study Period 2 (n=44) | 46 ± 8 | 49 ± 7 | NA ± NA | NA ± NA |
| Study Period 3 (n=37) | 47 ± 7 | 48 ± 8 | NA ± NA | NA ± NA |
| Study Period 4 (n=33) | 45 ± 7 | 48 ± 7 | NA ± NA | NA ± NA |
| Study Period 5 (n=26) | 45 ± 7 | 49 ± 7 | NA ± NA | NA ± NA |
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\[yellow=60,blue=-60\])
| color space parameter units | Normal/High Pressure Zone | Low Compression Zone |
|---|---|---|
| L color parameter | 56.3 ± 18.6 | 55.2 ± 17.6 |
| a color parameter | 9 ± 9.7 | 9.5 ± 9.2 |
| b color parameter | 8.2 ± 3.2 | 8.5 ± 3.2 |
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.
| mm | Normal/High Pressure Zone | Low Compression Zone |
|---|---|---|
| Thickness of Wound | 2.8 ± 3.2 | 3.4 ± 3.0 |
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.
| Participants | Normal/High Pressure Zone | Low Compression Zone |
|---|---|---|
| All experts agree zone has better appearance | 3 | 0 |
| All experts do not agree zone has better appearanc | 38 | 41 |
The patients were asked to complete a compliance form indicating how many hours the garment was worn each day.
| hours per day | Pressure Garment on Burn Wound |
|---|---|
| Compliance With Wearing Compression Garment | 20.4 ± 3.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pressure Garment on Burn Wound | — | 0/54 (0%) | 0/54 (0%) |
| Age Continuous(years) | Pressure Garment on Burn Wound |
|---|---|
| Mean | 36 ± 14 |
| Age, Customized(participants) | Pressure Garment on Burn Wound |
|---|---|
| 7-14 years | 3 |
| 15-30 years | 17 |
| 31-59 years | 34 |
| Sex: Female, Male(Participants) | Pressure Garment on Burn Wound |
|---|---|
| Female | 8 |
| Male | 46 |
| Region of Enrollment(participants) | Pressure Garment on Burn Wound |
|---|---|
| United States | 54 |
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