Trial Outcomes & Findings for Effectiveness of Pressure Garment Therapy After Burns (NCT NCT01005732)

NCT ID: NCT01005732

Last Updated: 2011-04-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
• Results posted on: 2011-04-04

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	54
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	10
Overall Study Death	1

Baseline Characteristics

Effectiveness of Pressure Garment Therapy After Burns

Baseline characteristics by cohort

Measure	Pressure Garment on Burn Wound n=54 Participants 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.
Age Continuous	36 years STANDARD_DEVIATION 14 • n=5 Participants
Age, Customized 7-14 years	3 participants n=5 Participants
Age, Customized 15-30 years	17 participants n=5 Participants
Age, Customized 31-59 years	34 participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)

Population: All Participants with available and evaluable measurement.

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.

Outcome measures

Measure	Normal/High Pressure Zone n=50 Participants Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Low Compression Zone n=50 Participants Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Kneecap Hardness of uninjured skin over a bony prominence is provided for comparison.	Uninjured Forearm Skin Hardness of uninjured forearm skin is provided for comparison.
Pressure Under Compression Garment	25 mm Hg Standard Deviation 6.3	6.4 mm Hg Standard Deviation 6.2	—	—

SECONDARY outcome

Timeframe: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)

Population: All Participants with available and evaluable measurement.

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.

Outcome measures

Measure	Normal/High Pressure Zone n=54 Participants Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Low Compression Zone n=54 Participants Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Kneecap n=54 Participants Hardness of uninjured skin over a bony prominence is provided for comparison.	Uninjured Forearm Skin n=54 Participants Hardness of uninjured forearm skin is provided for comparison.
Durometer (Hardness) of Wound Study Period 1 (n=51)	47 durometer units Standard Deviation 7	46 durometer units Standard Deviation 6	72 durometer units Standard Deviation 9	39 durometer units Standard Deviation 4
Durometer (Hardness) of Wound Study Period 2 (n=44)	46 durometer units Standard Deviation 8	49 durometer units Standard Deviation 7	NA durometer units Standard Deviation NA Measurement made at only one visit.	NA durometer units Standard Deviation NA Measurement made at only one visit.
Durometer (Hardness) of Wound Study Period 3 (n=37)	47 durometer units Standard Deviation 7	48 durometer units Standard Deviation 8	NA durometer units Standard Deviation NA Measurement made at only one visit.	NA durometer units Standard Deviation NA Measurement made at only one visit.
Durometer (Hardness) of Wound Study Period 4 (n=33)	45 durometer units Standard Deviation 7	48 durometer units Standard Deviation 7	NA durometer units Standard Deviation NA Measurement made at only one visit.	NA durometer units Standard Deviation NA Measurement made at only one visit.
Durometer (Hardness) of Wound Study Period 5 (n=26)	45 durometer units Standard Deviation 7	49 durometer units Standard Deviation 7	NA durometer units Standard Deviation NA Measurement made at only one visit.	NA durometer units Standard Deviation NA Measurement made at only one visit.

SECONDARY outcome

Timeframe: Approximately12 months (follow-up visits 5)

Population: All Participants with available and evaluable measurement.

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])

Outcome measures

Measure	Normal/High Pressure Zone n=81 Colorimeter observations Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Low Compression Zone n=81 Colorimeter observations Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Kneecap Hardness of uninjured skin over a bony prominence is provided for comparison.	Uninjured Forearm Skin Hardness of uninjured forearm skin is provided for comparison.
Color of Wound L color parameter	56.3 color space parameter units Standard Deviation 18.6	55.2 color space parameter units Standard Deviation 17.6	—	—
Color of Wound a color parameter	9 color space parameter units Standard Deviation 9.7	9.5 color space parameter units Standard Deviation 9.2	—	—
Color of Wound b color parameter	8.2 color space parameter units Standard Deviation 3.2	8.5 color space parameter units Standard Deviation 3.2	—	—

SECONDARY outcome

Timeframe: Approximately 12 months (follow-up visit 5)

Population: All Participants with available and evaluable measurement.

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.

Outcome measures

Measure	Normal/High Pressure Zone n=28 Participants Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Low Compression Zone n=28 Participants Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Kneecap Hardness of uninjured skin over a bony prominence is provided for comparison.	Uninjured Forearm Skin Hardness of uninjured forearm skin is provided for comparison.
Thickness of Wound	2.8 mm Standard Deviation 3.2	3.4 mm Standard Deviation 3.0	—	—

SECONDARY outcome

Timeframe: Approximately 12 months (follow-up visit 5)

Population: All Participants with available and evaluable measurement.

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.

Outcome measures

Measure	Normal/High Pressure Zone n=28 Participants Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Low Compression Zone n=28 Participants Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Kneecap Hardness of uninjured skin over a bony prominence is provided for comparison.	Uninjured Forearm Skin Hardness of uninjured forearm skin is provided for comparison.
Clinical Appearance of Wound All experts agree zone has better appearance	3 Participants	0 Participants	—	—
Clinical Appearance of Wound All experts do not agree zone has better appearanc	38 Participants	41 Participants	—	—

SECONDARY outcome

Timeframe: About 12 months (follow-up visit 5)

Population: All Participants with available and evaluable data.

The patients were asked to complete a compliance form indicating how many hours the garment was worn each day.

Outcome measures

Measure	Normal/High Pressure Zone n=27 Participants Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Low Compression Zone Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)	Kneecap Hardness of uninjured skin over a bony prominence is provided for comparison.	Uninjured Forearm Skin Hardness of uninjured forearm skin is provided for comparison.
Compliance With Wearing Compression Garment	20.4 hours per day Standard Deviation 3.9	—	—	—

Adverse Events

Pressure Garment on Burn Wound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Loren Engrav

University of Washington

Phone: 206-744-3209

Email: engrav@u.washington.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place