Electromotive Drug Administration of Magnesium Sulphate on Hypertrophic Scar

ConditionHypertrophic Scars

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-40

SponsorCairo University

About this trial

In this study 80 patients will be randomly assigned into two equal groups (40 patients for each group):

1. Group A: Experimental: Magnesium Sulphate Iontophoresis for Postburn Hypertrophic Scar The study group includes 40 postburn hypertrophic scar patients will receive Magnesium Sulphate iontophoresis twice a week for 4 weeks; in addition to their traditional physical therapy program (deep friction massage, stretching and pressure therapy). 2. Group B: Control: Traditional physical therapy for postburn hypertrophic scar This group includes 40 patients with postburn hypertrophic scar who will receive only the traditional PT (deep friction massage, stretching and pressure therapy) 2 sessions per week for 4 weeks

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1-Patient with hypertrophic scar (3-6) months after burn healing. 2-Age range between 20-40 years. 3-Male and female patients will participate in the study. 4-All patients have a post-burn hypertrophic scar at different body sites. 5-All patients enrolled on the study will have their informed consent.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Magnesium Sulphate Iontophoresis
Device
Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED) The phoresors II auto model PM850 IOMED allows the user to deliver a specific dose from 0 to 80 mA/min, control the current from 0 to 4 mA and automatically calculates required time for the selected dose. Current ramp-up and down, shut-off, error messages and safety checks are also performed automatically. The builtin option for manual current shut-off is an added safety feature (Teslim et al., 2013). * Electrodes: Active-Anode (Drug Delivery). * Drug Used: MgSO4 Aqueous Solution. * Drug Ion Polarity: Positive Polarity.
traditional physical therapy program
Other intervention
Deep friction massage, stretching and pressure therapy.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Group A: Magnesium Sulphate IontophoresisExperimental treatment 2 interventions

Group B: Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change of hypertrophic scar thickness

High frequency ultrasound is the most common used technique for scar assessment. Its inferior resolution compared to optical equivalents is mitigated by its superior penetration depth allowing thickness analysis, even in severe scar thickening. The working mechanism is based on refection of sound waves of structures with different acoustic impedances and the analysis of the refection time to determine the depth of the structure. The penetration depth ranges from the upper dermal layers to full-thickness skin and subcutaneous structures, depending on the employed frequency (Elrefaie et al., 2020).

Time frame

4 weeks

The change of patient and observer scar assessment scale score

The scar will be rated numerically on a ten-step scale by both the patient and doctor on six items: vascularity, pigmentation, thickness, relief, pliability, and surface area on the Observer Scale. The Patient Scale consists of pain, itchiness, color, stiffness, thickness, and irregularity of the scar. Minimal score means good progression and maximum score means the scare is worse (Lenzi et al., 2019).

Time frame

4 weeks

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: