Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Not Applicable

Completed

• Conditions: Pressure Ulcer
• Interventions: Other: Sham phenytoin phonophoresis; Other: Phenytoin phonophoresis

• Registration Number: NCT05542589
• Lead Sponsor: Cairo University

Brief Summary

Efficacy of phenytoin phonophoresis on pressure ulcer healing

Detailed Description

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 Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-15
• Primary Completion: 2023-02-14
• Study Completion: 2023-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham phenytoin phonophoresis group	Sham phenytoin phonophoresis	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.
Phenytoin phonophoresis group	Phenytoin phonophoresis	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.

Primary Outcome Measures

Name	Time	Method
Change in wound volume	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 .

Trial Locations

Locations (1)

Shaimaa Mohamed Ahmed Elsayeh; 🇪🇬 Cairo, New Cairo, Egypt