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NCT05341427 Clinical Trial

DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING

Burn Wound Clinical Trial

Official title:
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05341427
Other study ID # P.T.REC/012/003534
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date June 20, 2022

Study information
Verified date June 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to pulsed electromagnetic therapy in burn patients

Description:

It will be hypothesized that 1. Age may significantly affect burn wound healing's response to pulsed electromagnetic waves. 2. TBSA may significantly affect burn wound healing's response to pulsed electromagnetic waves 3. Depth of wound may significantly affect burn wound healing's response to pulsed electromagnetic waves 4. Wound healing stage may significantly affect burn wound healing's response to pulsed electromagnetic waves This study will be conducted at the in-patient burn units. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units. Pulsed electromagnetic waves will be performed for 60 min 3 times per week till healing (maximum 8 weeks) on the wound area. PEMF therapy will be as (duration: 60 minutes; frequency: 12 Hz; intensity: 12 Gauss)

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date June 20, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria Partial thickness Burn wound depth. Age ranges from 20-50 years. TBSA more than 15% Sufficient understanding to perform the tests. Exclusion Criteria Diabetic patients. Patients receiving immunosuppressive drugs. Associated co-morbidities, such as neurological diseases, malnutrition, and other in?ammatory and/or infectious diseases.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• electromagnetic device
electromagnetic waves for burn wound

Locations
Country Name City State
Egypt Cairo University Giza

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary wound healing rate tools for assessment of wound area changes before and after treatment maximum of 6 weeks
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