Comparison and Clinical Utility of the Portable Pressure Measuring Device for Garment Pressure Measurement on Hypertrophic Scar by Burn Injury During Compression Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Burns; Hypertrophic Scar
• Intervention / Treatment: Procedure: pressure monitoring

Detailed Description

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. To evaluate the effect of a pressure monitoring device, the investigators compared the skin test results (thickness, melanin, erythema, TEWL, and skin elasticity levels) between the two groups, from baseline measures immediately before the treatment and measures immediately after 2 months. The participants were made comfortable and acclimatized to room conditions. Room temperature was maintained at 20-25'C and relative humidity at 40-50 %. In the supine position, skin properties were measured. The thickness was measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin. Transepidermal water loss (TEWL) was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. Elasticity was measured using Cutometer SEM 580® (Courage-Khazaka Electronic GmbH, Cologne, Germany), which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the elasticity. Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained. The parameters consist of the following biomechanical skin properties: distenstibility, elasticity, and viscoelasticity. Distensibility means the length of total displacement from initial postion at maximum negative pressure. Gross elasticity means the ability of the skin to return to its initial position following displacement. Biologic elasticity means the ratio of immediate retraction to total displacement. Viscoelasticity means the ratio of delayed distension of immediate distension. Outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention. Possible complications (pain, ecchymosis, pain, skin abrasion, and swelling) were observed.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yeongdeungpo-Ku
    • Seoul, Yeongdeungpo-Ku, Korea, Republic of, 150-719,
      • Recruiting
      • Hangang Sacred Heart Hospital
      • Contact: daeun Kim; Phone Number: 82-2-2639-5900; Email: daeun@hallym.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pressure monitoring group; 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 for 2 months. Subjects were instructed to wear the garment 23 hours per day, removing them only for bathing.	Procedure: pressure monitoring; 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.
Active Comparator: conventional treatment group; In the conventional treatment group, non-surgical standard treatment of burn scars except for pressure monitoring was performed in the same manner. Subjects were instructed to wear the garment 23 hours per day, removing them only for bathing.	Procedure: pressure monitoring; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Change from baseline scar erythema at 8 weeks	The higher values indicating a redder skin.	8 weeks (before intervention and 8 weeks after intervention)
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)
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)

Collaborators and Investigators

• Sponsor: Hangang Sacred Heart Hospital
• Collaborators: Ministry of Health, Republic of Korea

Publications and helpful links

General Publications

• Harries CA, Pegg SP. Measuring pressure under burns pressure garments using the Oxford Pressure Monitor. Burns. 1989 Jun;15(3):187-9. doi: 10.1016/0305-4179(89)90180-0.
• 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.
• 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. doi: 10.1016/j.burns.2004.06.018.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Anticipated): August 10, 2020
• Study Completion (Anticipated): August 20, 2020

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: skin characteristics; burns; hypertrophic scar; compression therapy; pressure sensor
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Pathological Conditions, Anatomical; Fibrosis; Cicatrix; Burns; Hypertrophy; Cicatrix, Hypertrophic
• Other Study ID Numbers: HangangSHH-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No