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

NCT04456543 | Unknown DMC

• 1 other identifier: HangangSHH-11
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Hypertrophic Scar

Keywords

burns; compression therapy; skin characteristics; hypertrophic scar; pressure sensor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline scar pigmentation at 8 weeks

  8 weeks (before intervention and 8 weeks after intervention)

• Change from baseline scar erythema at 8 weeks

  8 weeks (before intervention and 8 weeks after intervention)

• Change from baseline skin dryness at 8 weeks

  8 weeks (before intervention and 8 weeks after intervention)

• Change from baseline skin elasticity at 8 weeks

  8 weeks (before intervention and 8 weeks after intervention)

Study Arms (2)

Pressure monitoring group

EXPERIMENTAL

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

conventional treatment group

ACTIVE COMPARATOR

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

Interventions

pressure monitoring PROCEDURE

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.

Pressure monitoring group; conventional treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Hangang Sacred Heart Hospital

Seoul, Yeongdeungpo-Ku, 150-719,, South Korea

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Burns; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: July 2, 2020
• Study Start: June 10, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 20, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)