Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Study Overview
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Brief Summary
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Efficacy of phenytoin phonophoresis on pressure ulcer healing

Detailed Description
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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.

Official Title
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Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Other: Phenytoin phonophoresis
* Other: Sham phenytoin phonophoresis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenytoin phonophoresis group<br>The topical phenytoin will be applied on the head of ultrasound and is usually given for 5-10 minute sessions, three times per week and six weeks as a total treatment duration. | Other: Phenytoin phonophoresis<br>* Phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.<br>|
| Sham Comparator: sham phenytoin phonophoresis group<br>The topical phenytoin will be applied on the head of ultrasound (sham ultrasound) and is usually given for 5-10 minute sessions, three times per week and six weeks as total treatment duration. | Other: Sham phenytoin phonophoresis<br>* Sham phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wound volume | 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 . | Baseline and six weeks after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phenytoin, phonophoresis, pressure ulcer