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Study for the Effects of Microcurrent Therapy on the Prevention and Healing of Brachioplasty Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066946
Recruitment Status : Enrolling by invitation
First Posted : August 26, 2019
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Organisation for Burns, Scar Aftercare and Research

Brief Summary:
Prospective, single-centre two-arm randomized controlled trial. Both groups receive standard wound care + hydration. The intervention group also receives microcurrent therapy. Patients with surgical incisions from bilateral Brachioplasty procedures will be included in this study. One arm will be randomized in the intervention group and one arm in the control group. Objective and subjective outcomes are registered. The aim of this study is to investigate whether the outcomes of the patients of the intervention group differ significantly from the patients in the control group.

Condition or disease Intervention/treatment Phase
Cicatrix Device: Microcurrent therapy Other: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a prospective, single centre, two-arm, single blinded randomized controlled study
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study for the Effects of Microcurrent Therapy on the Prevention and Healing of Brachioplasty Scars
Estimated Study Start Date : March 3, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Group 1 = Intervention group
Standard of care (hydration + silicone gel sheet) + Microcurrent
Device: Microcurrent therapy
Micro current therapy is a therapy to treat humans / animals using electric current with amperages flowing in the μA range. The device offers 2 treatment methods: manual treatment, which requires manual input corresponding to the mentioned parameters, and automatic treatment which, depending on the clinical picture and the currently measured resistance between the electrodes, allows the device to automatically change the mentioned parameters. For this study the investigators use an automatic treatment with predefined settings. This automatic programme consists of a variation of 20 different frequency settings during 17 minutes. This programme is repeated one time which leads to a total treatment time of 34 minutes. The intensity setting for the treatment is between 200 and 350 µA. The treatment is applied 5x per week in the first 6 weeks. The treatment is stopped after six weeks.

Other: Standard of care

Standard of Care consists of:

During the first two weeks:

  • Histoacryl glue to close the surgical incisions.
  • Suture strips to keep the wound closed.
  • Isobetadine Dermicum as anti-septic treatment
  • Dry wound dressings during the first 2 weeks.
  • Tubigrip

From two weeks until three months:

• Hydration with hydrating crème 2x per day (not within 4 hours before microcurrent treatment.

From three months onwards:

• Silicone gel sheet.


Active Comparator: Group 2 = Control Group
Standard of care (hydration + silicone gel sheet)
Other: Standard of care

Standard of Care consists of:

During the first two weeks:

  • Histoacryl glue to close the surgical incisions.
  • Suture strips to keep the wound closed.
  • Isobetadine Dermicum as anti-septic treatment
  • Dry wound dressings during the first 2 weeks.
  • Tubigrip

From two weeks until three months:

• Hydration with hydrating crème 2x per day (not within 4 hours before microcurrent treatment.

From three months onwards:

• Silicone gel sheet.





Primary Outcome Measures :
  1. Assessing the change of POSAS Patient Scale Total Sum of Scores [ Time Frame: At baseline (15 days after surgery) - 180 days after surgery. ]
    The POSAS Patient Scale contains six items (pain, itch, colour, thickness, pliability, texture) that are scored numerically on a ten-step scale from 1 (= healthy skin) to 10 (= worst imaginable scar). Together they make up the 'Total Sum of Scores'.


Secondary Outcome Measures :
  1. POSAS Observer Scale Total Sum of Scores [ Time Frame: At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery) ]
    The POSAS Observer Scale contains six items (vascularity, pigmentation, colour, thickness, pliability, surface) that are scored numerically on a ten-step scale from 1 (= healthy skin) to 10 (= worst imaginable scar). Together they make up the 'Total Sum of Scores'.

  2. Colour measurement with MexaMeter [ Time Frame: At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery) ]
    Light is generated by a source lamp and is dispersed into its constituent wavelengths in a monochromator which results in a narrow band of the dispersed spectrum passing from the exit slit of the device. Suitable optics is used to lead this light, of a narrow wavelength band, to the sample being measured. A sample with an UV/Visible chromophore sample absorbs a certain amount of light and a suitable detector in the spectrophotometer detects the remaining light. The Beer-Lambert law is then applied to determine the concentration of the remaining light in the sample at a specific wavelength. The most commonly used wavelengths are 568 nm (green), 660 nm (red) and 880 nm (infrared). A melanin index can be computed from the results of red and infrared wavelengths and an erythema index is calculated from the results of green and red wavelength. Draaijers et al. stated that it is easier to understand the meaning of the erythema and the melanin index than the L*a*b* values.

  3. Elasticity measurement with Cutometer [ Time Frame: At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery) ]
    The Cutometer® is designed to measure elasticity of the upper skin layer using negative pressure which mechanically deforms the skin. The measuring principle is based on the suction method. Negative pressure is created in the device and the skin is drawn into the aperture of the probe and released again after a defined time. Inside the probe the penetration depth is determined by a non-contact optical measuring system. This measurement principle allows data collection on the elastic and mechanical properties of skin surface and enables objective quantification of skin aging. The Cutometer® measures the vertical deformation of the skin in millimetres when the skin is pulled by means of a controlled vacuum into the circular aperture of the probe.

  4. Generic assessment of Quality of Life with EQ5D [ Time Frame: At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery) ]
    The EQ-5D descriptive system encompasses five questions covering five dimensions: mobility, self-care, usual activities, pain and anxiety/depression. For each dimension, respondents value their health by reporting whether they are experiencing 1 = ''none'', 2 = ''moderate'' or 3 = ''extreme problems''. A unique EQ-5D health state is defined by combining the responses (1, 2 or 3) on each of the five dimensions. The EQ VAS is a vertical 20-cm line graded from 0 = ''worst possible health state'' to 100 = ''best possible health state'', on which the respondent is asked to mark his or her own current state of health. The EQ-5D health state can also be converted into a weighted index. The conversion into the index is based on norm values obtained in population-based enquiries. The EQ-5D index ranges from 0.594 = ''death or worse than death'' to 1 = ''full health''.

  5. Disease specific assessment of Quality of Life with DLQI [ Time Frame: At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery) ]

    The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above.

    There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subjects must be between 18 and 75 years old.
  • Having received surgical treatment, more specific bilateral brachioplasty.

Exclusion Criteria:

  • Subjects who have an implanted or other electrical stimulatory device such as pacemakers, or any other implanted electronic nerve, muscle or tissue stimulation.
  • Subjects with implanted hearing aids.
  • Subjects with a history of seizures, epilepsy.
  • Women who are pregnant at the time of enrolment
  • Central neurological conditions
  • Peripheral paralysis
  • Patients with diabetes mellitus
  • Subjects unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066946


Locations
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Belgium
Organisation for burns, scar after-care and research
Antwerp, Belgium, B-2170
Sponsors and Collaborators
Organisation for Burns, Scar Aftercare and Research
Investigators
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Study Director: Peter Moortgat OSCARE npo
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Responsible Party: Organisation for Burns, Scar Aftercare and Research
ClinicalTrials.gov Identifier: NCT04066946    
Other Study ID Numbers: CIP0020-201901-MCU
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Organisation for Burns, Scar Aftercare and Research:
scar
arm
brachioplasty
microcurrent
interventional study
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes