Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Sponsor

Cairo University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05542589

Collaborator

(none)

Enrollment

Location

Arms

8.3

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy of phenytoin phonophoresis on pressure ulcer healing

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer	Other: Phenytoin phonophoresis Other: Sham phenytoin phonophoresis	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Oct 28, 2022

Anticipated Study Completion Date :

Nov 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phenytoin phonophoresis group 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 Phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.
Sham Comparator: sham phenytoin phonophoresis group 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 Sham phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.

Arm

Intervention/Treatment

Experimental: Phenytoin phonophoresis group

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

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

Sham Comparator: sham phenytoin phonophoresis group

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

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

Outcome Measures

Primary Outcome Measures

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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.