NCT04456543

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

Status unknown NA Last updated 2 July 2020

What this trial tests

NA trial testing pressure monitoring in Burns in 48 participants. Status unknown.

Timeline

10 June 2020

Primary endpoint
10 August 2020

20 August 2020

Quick facts

Lead sponsor	Hangang Sacred Heart Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	48
Start date	10 June 2020
Primary completion	10 August 2020
Estimated completion	20 August 2020
Sites	1 location across South Korea

Drugs / interventions tested

• pressure monitoring

Conditions studied

• Burns — all drugs for Burns →
• Hypertrophic Scar — all drugs for Hypertrophic Scar →

Sponsor

Hangang Sacred Heart Hospital

Who can join

Adults 18 to 70, any sex, with Burns or Hypertrophic Scar. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pressure-garment therapy for preventing hypertrophic scarring after burn injury.
   Harris IM, Lee KC, Deeks JJ, Moore DJ, et al · · 2024 · cited 8× · PMID 38189494 · DOI 10.1002/14651858.cd013530.pub2
2. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148
3. Clinical Utility of the Portable Pressure-Measuring Device for Compression Garment Pressure Measurement on Hypertrophic Scars by Burn Injury during Compression Therapy.
   Joo SY, Cho YS, Yoo JW, Kim YH, et al · · 2022 · cited 1× · PMID 36431220 · DOI 10.3390/jcm11226743