Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Pressure Ulcer Clinical Trial

Official title:

Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05542589
• Other study ID #: P.T.REC/012/003632
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy of phenytoin phonophoresis on pressure ulcer healing

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Egypt	Shaimaa Mohamed Ahmed Elsayeh	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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