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

Primary Purpose

Burns, Hypertrophic Scar

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pressure monitoring
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring burns, compression therapy, skin characteristics, hypertrophic scar, pressure sensor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hangang Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pressure monitoring group

conventional treatment group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline scar thickness at 8 weeks
hypertrophic scar thickness. The thicker the measurement thickness, the larger the number.

Secondary Outcome Measures

Change from baseline scar pigmentation at 8 weeks
measurement of melanin level. The higher values indicating a darker
Change from baseline scar erythema at 8 weeks
The higher values indicating a redder skin.
Change from baseline skin dryness at 8 weeks
measurement of transepidermal water loss. The higher the measurement, the dryer the skin.
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

Full Information

First Posted
June 8, 2020
Last Updated
June 30, 2020
Sponsor
Hangang Sacred Heart Hospital
Collaborators
Ministry of Health, Republic of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04456543
Brief Title
Comparison and Clinical Utility of the Portable Pressure Measuring Device for Garment Pressure Measurement on Hypertrophic Scar by Burn Injury During Compression Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
August 10, 2020 (Anticipated)
Study Completion Date
August 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
Ministry of Health, Republic of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Hypertrophic Scar
Keywords
burns, compression therapy, skin characteristics, hypertrophic scar, pressure sensor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients with partial-/full-thickness burns, which spontaneously healed or required skin grafting, from the Department of Rehabilitation Medicine at the Hangang Sacred Heart Hospital of Korea
Masking
ParticipantOutcomes Assessor
Masking Description
The participants are randomly devided into two groups. Outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pressure monitoring group
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional treatment group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
pressure monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline scar thickness at 8 weeks
Description
hypertrophic scar thickness. The thicker the measurement thickness, the larger the number.
Time Frame
8 weeks (before intervention and 8 weeks after intervention)
Secondary Outcome Measure Information:
Title
Change from baseline scar pigmentation at 8 weeks
Description
measurement of melanin level. The higher values indicating a darker
Time Frame
8 weeks (before intervention and 8 weeks after intervention)
Title
Change from baseline scar erythema at 8 weeks
Description
The higher values indicating a redder skin.
Time Frame
8 weeks (before intervention and 8 weeks after intervention)
Title
Change from baseline skin dryness at 8 weeks
Description
measurement of transepidermal water loss. The higher the measurement, the dryer the skin.
Time Frame
8 weeks (before intervention and 8 weeks after intervention)
Title
Change from baseline skin elasticity at 8 weeks
Description
Biologic elasticity means the ratio of immediate retraction to total displacement using suction. The higher the measurement, the more elasticity
Time Frame
8 weeks (before intervention and 8 weeks after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
State/Province
Yeongdeungpo-Ku
ZIP/Postal Code
150-719,
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
daeun Kim
Phone
82-2-2639-5900
Email
daeun@hallym.or.kr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2757769
Citation
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.
Results Reference
background
PubMed Identifier
20375696
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.
Results Reference
background
PubMed Identifier
16413399
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. doi: 10.1016/j.burns.2004.06.018.
Results Reference
background

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

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