Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649188
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Electromotive Drug Administration of Magnesium Sulphate on Hypertrophic Scar
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Electromotive Drug Administration of Magnesium Sulphate on Hypertrophic Scar Post-Burn
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
1 Assessment measures and procedures
1 High resolution ultrasonography Time Frame Change of hypertrophic scar thickness from the beginning of treatment to the end of treatment after 4 and 12 weeks from the beginning of treatment
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
2 Patient and observer scar assessment scale Time Frame Assessing the change of patient and observer scar assessment scale score from baseline beginning of treatment to 4 and 12 weeks after treatment
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
2 Treatment procedures
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 mAmin 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 Prior to intervention skin sensation will be assessed using warm water in a test-tube temperature pin prick pain and cotton wool light touch to ascertain the skin sensitivity
Before each treatment the surface area of the scar will be cleaned with cotton wool and alcohol to reduce skin resistance 25 ML MgSO4 will be applied to the active positive electrode via a syringe with concentration 100 mgcm2 its available in hospitals and not found in pharmacies active electrode will be placed directly over the hypertrophic scar The dispersive electrode will be applied to the skin 6 inch distal from the active electrode Evans et al 2001
The dose needed will be selected in the device which is 75 mAmin Teslim et al 2013 then the current will be increased gradually depending on subject tolerance ranging from 2 to 4 mA the device will automatically calculate the required time for the selected dose The interventions will be repeated twice a week for 4 weeks Teslim et al 2013 If a subject reports any sensation other than tingling the treatment will be stopped the electrodes will be removed and the skin will be inspected Evans et al 2001
1 High resolution ultrasonography Time Frame Change of hypertrophic scar thickness from the beginning of treatment to the end of treatment after 4 and 12 weeks from the beginning of treatment
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
2 Patient and observer scar assessment scale Time Frame Assessing the change of patient and observer scar assessment scale score from baseline beginning of treatment to 4 and 12 weeks after treatment
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
2 Treatment procedures
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 mAmin 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 Prior to intervention skin sensation will be assessed using warm water in a test-tube temperature pin prick pain and cotton wool light touch to ascertain the skin sensitivity
Before each treatment the surface area of the scar will be cleaned with cotton wool and alcohol to reduce skin resistance 25 ML MgSO4 will be applied to the active positive electrode via a syringe with concentration 100 mgcm2 its available in hospitals and not found in pharmacies active electrode will be placed directly over the hypertrophic scar The dispersive electrode will be applied to the skin 6 inch distal from the active electrode Evans et al 2001
The dose needed will be selected in the device which is 75 mAmin Teslim et al 2013 then the current will be increased gradually depending on subject tolerance ranging from 2 to 4 mA the device will automatically calculate the required time for the selected dose The interventions will be repeated twice a week for 4 weeks Teslim et al 2013 If a subject reports any sensation other than tingling the treatment will be stopped the electrodes will be removed and the skin will be inspected Evans et al 2001
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None