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

NCT04066946 | Completed

• 1 other identifier: CIP0020-201901-MCU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix

Keywords

scar; arm; brachioplasty; microcurrent; interventional study

Outcome Measures

Primary Outcomes (1)

• Assessing the change of POSAS Patient Scale Total Sum of Scores

  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'.

  At baseline (15 days after surgery) - 180 days after surgery.

Secondary Outcomes (5)

• POSAS Observer Scale Total Sum of Scores

  At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery)

• Colour measurement with MexaMeter

  At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery)

• Elasticity measurement with Cutometer

  At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery)

• Generic assessment of Quality of Life with EQ5D

  At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery)

• Disease specific assessment of Quality of Life with DLQI

  At visit 1 (15 days after surgery) - at visit 2 (90 days after surgery) - at visit 3 (180 days after surgery)

Study Arms (2)

Group 1 = Intervention group

EXPERIMENTAL

Standard of care (hydration + silicone gel sheet) + Microcurrent

Device: Microcurrent therapy; Other: Standard of care

Group 2 = Control Group

ACTIVE COMPARATOR

Standard of care (hydration + silicone gel sheet)

Other: Standard of care

Interventions

Microcurrent therapy DEVICE

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.

Group 1 = Intervention group

Standard of care OTHER

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.

Group 1 = Intervention group; Group 2 = Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organisation for Burns, Scar Aftercare and Research: lead

Study Sites (1)

Organisation for burns, scar after-care and research

Antwerp, B-2170, Belgium

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Peter Moortgat

  OSCARE npo

  STUDY DIRECTOR

Study Design

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

Model Details: This study is a prospective, single centre, two-arm, single blinded randomized controlled study

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 26, 2019
• Study Start: March 3, 2020
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: April 17, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)