<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04456543</url>
  </required_header>
  <id_info>
    <org_study_id>HangangSHH-11</org_study_id>
    <nct_id>NCT04456543</nct_id>
  </id_info>
  <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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hangang Sacred Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Republic of Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hangang Sacred Heart Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators developed a portable pressure measuring device using silicon piezoresistive&#xD;
      pressure sensors. As PicoPress® is the most accurate (i.e., lowest variation and error)&#xD;
      manometric sensor for pressure measurement, the investigators used it to compare and examine&#xD;
      the accuracy of the proposed device regarding in vitro pressure measurements. The purpose of&#xD;
      this study was to determine the effectiveness of pressure garment therapy using proposed&#xD;
      device with objective data obtained with a randomized within wound comparison. Pressure&#xD;
      measurements were acquired through a readout circuit consisting of an analog-to-digital&#xD;
      converter, a microprocessor, and a Bluetooth transmission module for wireless data&#xD;
      transmission to an external device. The mean pressure values measured by the sensors were&#xD;
      compared to those obtained from PicoPress®. This was a double-blinded, randomized, controlled&#xD;
      trial of patients with hypertrophic scars. In the pressure monitoring group, garment&#xD;
      pressures were monitored using the portable pressure measuring device, and the compression&#xD;
      garment was adjusted so that the pressure was maintained at the therapeutic range of 15 - 25&#xD;
      mmHg. In the control group, non-surgical standard treatment of burn scars except for pressure&#xD;
      monitoring was performed in the same manner.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators developed a portable pressure measuring device using silicon piezoresistive&#xD;
      pressure sensors. As PicoPress® is the most accurate (i.e., lowest variation and error)&#xD;
      manometric sensor for pressure measurement, the investigators used it to compare and examine&#xD;
      the accuracy of the proposed device regarding in vitro pressure measurements. The purpose of&#xD;
      this study was to determine the effectiveness of pressure garment therapy using proposed&#xD;
      device with objective data obtained with a randomized within wound comparison. Pressure&#xD;
      measurements were acquired through a readout circuit consisting of an analog-to-digital&#xD;
      converter, a microprocessor, and a Bluetooth transmission module for wireless data&#xD;
      transmission to an external device. The mean pressure values measured by the sensors were&#xD;
      compared to those obtained from PicoPress®. This was a double-blinded, randomized, controlled&#xD;
      trial of patients with hypertrophic scars. In the pressure monitoring group, garment&#xD;
      pressures were monitored using the portable pressure measuring device, and the compression&#xD;
      garment was adjusted so that the pressure was maintained at the therapeutic range of 15 - 25&#xD;
      mmHg. In the control group, non-surgical standard treatment of burn scars except for pressure&#xD;
      monitoring was performed in the same manner. To evaluate the effect of a pressure monitoring&#xD;
      device, the investigators compared the skin test results (thickness, melanin, erythema, TEWL,&#xD;
      and skin elasticity levels) between the two groups, from baseline measures immediately before&#xD;
      the treatment and measures immediately after 2 months. The participants were made comfortable&#xD;
      and acclimatized to room conditions. Room temperature was maintained at 20-25'C and relative&#xD;
      humidity at 40-50 %. In the supine position, skin properties were measured. The thickness was&#xD;
      measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18,&#xD;
      Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the&#xD;
      severity of erythema. The higher values indicating a darker and redder skin. Transepidermal&#xD;
      water loss (TEWL) was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany),&#xD;
      which is used for evaluating water evaporation. Elasticity was measured using Cutometer SEM&#xD;
      580® (Courage-Khazaka Electronic GmbH, Cologne, Germany), which applies negative pressure&#xD;
      (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the&#xD;
      elasticity. Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and&#xD;
      this consists of a complete cycle. Three measurement cycles were conducted, and the average&#xD;
      values were obtained. The parameters consist of the following biomechanical skin properties:&#xD;
      distenstibility, elasticity, and viscoelasticity. Distensibility means the length of total&#xD;
      displacement from initial postion at maximum negative pressure. Gross elasticity means the&#xD;
      ability of the skin to return to its initial position following displacement. Biologic&#xD;
      elasticity means the ratio of immediate retraction to total displacement. Viscoelasticity&#xD;
      means the ratio of delayed distension of immediate distension. Outcome measurements and data&#xD;
      analyses were performed by a trained and blinded outcome assessor who was not involved in the&#xD;
      intervention. Possible complications (pain, ecchymosis, pain, skin abrasion, and swelling)&#xD;
      were observed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Anticipated">August 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 10, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline scar thickness at 8 weeks</measure>
    <time_frame>8 weeks (before intervention and 8 weeks after intervention)</time_frame>
    <description>hypertrophic scar thickness. The thicker the measurement thickness, the larger the number.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline scar pigmentation at 8 weeks</measure>
    <time_frame>8 weeks (before intervention and 8 weeks after intervention)</time_frame>
    <description>measurement of melanin level. The higher values indicating a darker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline scar erythema at 8 weeks</measure>
    <time_frame>8 weeks (before intervention and 8 weeks after intervention)</time_frame>
    <description>The higher values indicating a redder skin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline skin dryness at 8 weeks</measure>
    <time_frame>8 weeks (before intervention and 8 weeks after intervention)</time_frame>
    <description>measurement of transepidermal water loss. The higher the measurement, the dryer the skin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline skin elasticity at 8 weeks</measure>
    <time_frame>8 weeks (before intervention and 8 weeks after intervention)</time_frame>
    <description>Biologic elasticity means the ratio of immediate retraction to total displacement using suction. The higher the measurement, the more elasticity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Burns</condition>
  <condition>Hypertrophic Scar</condition>
  <arm_group>
    <arm_group_label>Pressure monitoring group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pressure monitoring</intervention_name>
    <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.</description>
    <arm_group_label>Pressure monitoring group</arm_group_label>
    <arm_group_label>conventional treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult over 18&#xD;
&#xD;
          -  partial-/full-thickness burns&#xD;
&#xD;
          -  fully epithelialization after spontaneously healed or required skin grafting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  open wounds&#xD;
&#xD;
          -  infection on the burn scars&#xD;
&#xD;
          -  those taking steroids for the scars&#xD;
&#xD;
          -  condition affecting wound healing (e.g., diabetes)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hangang Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Yeongdeungpo-Ku</state>
        <zip>150-719,</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>daeun Kim</last_name>
      <phone>82-2-2639-5900</phone>
      <email>daeun@hallym.or.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>2757769</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20375696</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16413399</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>burns</keyword>
  <keyword>compression therapy</keyword>
  <keyword>skin characteristics</keyword>
  <keyword>hypertrophic scar</keyword>
  <keyword>pressure sensor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</mesh_term>
    <mesh_term>Cicatrix, Hypertrophic</mesh_term>
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04456543
org study id: HangangSHH-11
nct id: NCT04456543
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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
primary purpose: Treatment
masking: Double (Participant, Outcomes 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.
measure: Change from baseline scar thickness at 8 weeks
time frame: 8 weeks (before intervention and 8 weeks after intervention)
description: hypertrophic scar thickness. The thicker the measurement thickness, the larger the number.
measure: Change from baseline scar pigmentation at 8 weeks
time frame: 8 weeks (before intervention and 8 weeks after intervention)
description: measurement of melanin level. The higher values indicating a darker
measure: Change from baseline scar erythema at 8 weeks
time frame: 8 weeks (before intervention and 8 weeks after intervention)
description: The higher values indicating a redder skin.
measure: Change from baseline skin dryness at 8 weeks
time frame: 8 weeks (before intervention and 8 weeks after intervention)
description: measurement of transepidermal water loss. The higher the measurement, the dryer the skin.
measure: Change from baseline skin elasticity at 8 weeks
time frame: 8 weeks (before intervention and 8 weeks after intervention)
description: Biologic elasticity means the ratio of immediate retraction to total displacement using suction. The higher the measurement, the more elasticity
arm group label: Pressure monitoring group
arm group type: Experimental
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 group label: conventional treatment group
arm group type: Active Comparator
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: pressure monitoring
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.
arm group label: Pressure monitoring group
arm group label: conventional treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
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.
PMID: 2757769
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.
PMID: 20375696
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.
PMID: 16413399
responsible party type: Sponsor
mesh term: Hypertrophy
mesh term: Cicatrix, Hypertrophic
mesh term: Burns
sharing ipd: No