Burns Clinical Trial
Official title:
Comparison and Clinical Utility of the Portable Pressure Measuring Device for Garment Pressure Measurement on Hypertrophic Scar by Burn Injury During Compression Therapy
Verified date | June 2020 |
Source | Hangang Sacred Heart Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators developed a portable pressure measuring device using silicon piezoresistive pressure sensors. As PicoPress® is the most accurate (i.e., lowest variation and error) manometric sensor for pressure measurement, the investigators used it to compare and examine the accuracy of the proposed device regarding in vitro pressure measurements. The purpose of this study was to determine the effectiveness of pressure garment therapy using proposed device with objective data obtained with a randomized within wound comparison. Pressure measurements were acquired through a readout circuit consisting of an analog-to-digital converter, a microprocessor, and a Bluetooth transmission module for wireless data transmission to an external device. The mean pressure values measured by the sensors were compared to those obtained from PicoPress®. This was a double-blinded, randomized, controlled trial of patients with hypertrophic scars. In the pressure monitoring group, garment pressures were monitored using the portable pressure measuring device, and the compression garment was adjusted so that the pressure was maintained at the therapeutic range of 15 - 25 mmHg. In the control group, non-surgical standard treatment of burn scars except for pressure monitoring was performed in the same manner.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | August 20, 2020 |
Est. primary completion date | August 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Adult over 18 - partial-/full-thickness burns - fully epithelialization after spontaneously healed or required skin grafting Exclusion Criteria: - open wounds - infection on the burn scars - those taking steroids for the scars - condition affecting wound healing (e.g., diabetes) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hangang Sacred Heart Hospital | Seoul | Yeongdeungpo-Ku |
Lead Sponsor | Collaborator |
---|---|
Hangang Sacred Heart Hospital | Ministry of Health, Republic of Korea |
Korea, Republic of,
Harries CA, Pegg SP. Measuring pressure under burns pressure garments using the Oxford Pressure Monitor. Burns. 1989 Jun;15(3):187-9. — View Citation
Li-Tsang CW, Zheng YP, Lau JC. A randomized clinical trial to study the effect of silicone gel dressing and pressure therapy on posttraumatic hypertrophic scars. J Burn Care Res. 2010 May-Jun;31(3):448-57. doi: 10.1097/BCR.0b013e3181db52a7. — View Citation
Macintyre L, Baird M. Pressure garments for use in the treatment of hypertrophic scars--a review of the problems associated with their use. Burns. 2006 Feb;32(1):10-5. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline scar thickness at 8 weeks | hypertrophic scar thickness. The thicker the measurement thickness, the larger the number. | 8 weeks (before intervention and 8 weeks after intervention) | |
Secondary | Change from baseline scar pigmentation at 8 weeks | measurement of melanin level. The higher values indicating a darker | 8 weeks (before intervention and 8 weeks after intervention) | |
Secondary | Change from baseline scar erythema at 8 weeks | The higher values indicating a redder skin. | 8 weeks (before intervention and 8 weeks after intervention) | |
Secondary | Change from baseline skin dryness at 8 weeks | measurement of transepidermal water loss. The higher the measurement, the dryer the skin. | 8 weeks (before intervention and 8 weeks after intervention) | |
Secondary | Change from baseline skin elasticity at 8 weeks | Biologic elasticity means the ratio of immediate retraction to total displacement using suction. The higher the measurement, the more elasticity | 8 weeks (before intervention and 8 weeks after intervention) |
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