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BurnsNCT04456543

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

A study testing pressure monitoring in people with Burns and Hypertrophic Scar, run by Hangang Sacred Heart Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Burns, Hypertrophic Scar
What is being tested?
pressure monitoring
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSouth Korea
Study dates
10 Jun 2020to 20 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult over 18
  • partial-/full-thickness burns
  • fully epithelialization after spontaneously healed or required skin grafting

Who cannot join

  • open wounds
  • infection on the burn scars
  • those taking steroids for the scars
  • condition affecting wound healing (e.g., diabetes)

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting
  • Hangang Sacred Heart Hospital

    Seoul, Yeongdeungpo-Ku, 150-719,

    daeun Kim, 82-2-2639-5900, daeun@hallym.or.kr

    Recruiting

Other trials in South Korea

About this study

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.

Read the 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.

Being tested
pressure monitoring
Keywords
burns, compression therapy, skin characteristics, hypertrophic scar, pressure sensor
Medical subject headings
Burns, Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pressure monitoringProcedure or surgery

    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.

Study groups in NCT04456543
Study groupRoleWhat they receive
Pressure monitoring groupExperimentalIn 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.
Receives: Procedure: pressure monitoring
conventional treatment groupActive comparatorIn 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.
Receives: Procedure: pressure monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline scar thickness at 8 weeks

    hypertrophic scar thickness. The thicker the measurement thickness, the larger the number.

    Measured: 8 weeks (before intervention and 8 weeks after intervention)

Secondary outcomes (4)
  1. Change from baseline scar pigmentation at 8 weeks

    measurement of melanin level. The higher values indicating a darker

    Measured: 8 weeks (before intervention and 8 weeks after intervention)

  2. Change from baseline scar erythema at 8 weeks

    The higher values indicating a redder skin.

    Measured: 8 weeks (before intervention and 8 weeks after intervention)

  3. Change from baseline skin dryness at 8 weeks

    measurement of transepidermal water loss. The higher the measurement, the dryer the skin.

    Measured: 8 weeks (before intervention and 8 weeks after intervention)

  4. 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

    Measured: 8 weeks (before intervention and 8 weeks after intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2020
  2. Study start10 Jun 2020
  3. Primary completion10 Aug 2020 (estimated)
  4. Study completion20 Aug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04456543
Sponsor's protocol ID
HangangSHH-11
Status last verified
Jun 2020
First submitted
8 Jun 2020
Last updated
2 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 2757769
  • 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.

    PubMed 20375696
  • 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.

    PubMed 16413399

Questions about this trial

What is this clinical trial studying?

A study testing pressure monitoring in people with Burns and Hypertrophic Scar, run by Hangang Sacred Heart Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline scar thickness at 8 weeks (time frame: 8 weeks (before intervention and 8 weeks after intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04456543, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.

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