Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Cairo University40 enrolled

Overview

Efficacy of phenytoin phonophoresis on pressure ulcer healing

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pressure Ulcer

Interventions

Phenytoin phonophoresisOTHER

Phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.

Sham phenytoin phonophoresisOTHER

Sham phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, Egypt

Outcomes

Primary Outcomes

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 .

Time frame: Baseline and six weeks after the intervention

Data from ClinicalTrials.gov

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