Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Cairo University (CU)

Status: Completed

Conditions: Pressure Ulcer

Treatments: Other: Sham phenytoin phonophoresis; Other: Phenytoin phonophoresis

Study type: Interventional

Funder types: Other

Identifiers

NCT05542589

P.T.REC/012/003632

Details and patient eligibility

About

Efficacy of phenytoin phonophoresis on pressure ulcer healing

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Phenytoin phonophoresis group

Experimental group

Description:

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.

Treatment:

Other: Phenytoin phonophoresis

sham phenytoin phonophoresis group

Sham Comparator group

Description:

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.

Treatment:

Other: Sham phenytoin phonophoresis