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

NCT04066946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-17

No results posted yet for this study

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.

Conditions

  • Cicatrix

Interventions

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.

Sponsors & Collaborators

  • Organisation for Burns, Scar Aftercare and Research

    lead OTHER

Principal Investigators

  • Peter Moortgat · OSCARE npo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2024-04-16
Completion
2024-04-16

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066946 on ClinicalTrials.gov