Shaimaa Mohamed Ahmed Elsayeh
Cairo, New Cairo, 02, Egypt
NCT Number: NCT05542589
Efficacy of phenytoin phonophoresis on pressure ulcer healing
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Notify Me40 year–60 year
All sexes
Interventional
Not applicable
Cairo, New Cairo, 02, Egypt
The purpose of the study is to evaluate the therapeutic effect of phenytoin phonophoresis on the healing of pressure ulcers.
Subjects: Forty patients suffering from pressure ulcers will be randomly divided into two equal groups each one has 20 patients, they will be selected from Al Kaser Al Aini. In this study, the patients will be randomly assigned into two equal groups (20 patients for each group) and will receive the treatment program three sessions per week for 6 weeks as a total period of treatment.
Phenytoin phonophoresis group (Study group): This group includes 20 patients with pressure ulcers who will receive topical phenytoin with ultrasound in addition to their conventional treatment.
Phenytoin phonophoresis group (Control group): This group will include 20 patients with pressure ulcers who will receive phenytoin with a placebo ultrasound.
Equipment and tools:
Measurement equipment: Saline injection method. Therapeutic equipment: Ultrasonic device, topical phenytoin, and hydrogel sheet.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Ages range from 40 to 60 years, both genders, patients with pressure ulcers, and patients who will sign their informed consent.
Exclusion criteria
Patients with a history of hypersensitivity to phenytoin, pneumonia, immune deficiency, infection, advanced diabetic patients, radiotherapy in the ulcer area, osteomyelitis in the ulcer area, venous ulcers, burn wounds, leprosy trophic ulcers, traumatic wounds, pregnant subjects, terminally ill subjects, and the use of antineoplastic agents or systemic glucocorticosteroids.
Phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.
Sham phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.
Time frame: Baseline and six weeks after the intervention
by saline gel injection method
Amount of saline gel will be applied by steralized single use syringe in wound cavity then score this amount Amount of saline gel will be applied by steralized single use syringe in wound cavity then score this amount
Amount of saline gel will be applied by steralized single use syringe in wound cavity then score this amount .
Cairo University
Other
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