Electromotive Drug Administration of Magnesium Sulphate on Hypertrophic Scar

NCT06649188 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005334
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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

Conditions

Hypertrophic Scars

Keywords

Iontophoresis; Post burn

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  4 weeks

Study Arms (2)

Group A: Magnesium Sulphate Iontophoresis

EXPERIMENTAL

Device: Magnesium Sulphate Iontophoresis; Other: traditional physical therapy program

Group B: Control

SHAM COMPARATOR

Other: traditional physical therapy program

Interventions

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.

Group A: Magnesium Sulphate Iontophoresis

traditional physical therapy program OTHER

Deep friction massage, stretching and pressure therapy.

Group A: Magnesium Sulphate Iontophoresis; Group B: Control

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 1-Patients with prior medical histories of cardiac arrhythmias. 2-Patients with cardiac pacemakers. 3-Patients with orthopaedic implants. 4-Areas of skin with lesions and impaired sensation. 5-During pregnancy and breastfeeding. 6-Patient with diabetes mellitus. 7-Patients with a history of hypersensitivity or adverse reactions associated with (MgSO4).
• Recent MgSO4 administration 6 months before the study. 9-Any subject complaining of psychiatric disorders or neurological disorders such as myasthenia gravis

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aya Gamal Elsayed, PHD

CONTACT

+0201001475959; drayasa3ada@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: November 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 15, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

EG (1)