Back to resultsDEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
Primary Purpose
Burn Wound
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
electromagnetic device
Sponsored by
About this trial
This is an interventional treatment trial for Burn Wound
Eligibility Criteria
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 inflammatory and/or infectious diseases.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
burn wound receiving electromagnetic therapy
Arm Description
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 of Cairo university hospitals
Outcomes
Primary Outcome Measures
wound healing rate
tools for assessment of wound area changes before and after treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05341427
Brief Title
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
Official Title
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
June 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
Detailed Description
It will be hypothesized that
Age may significantly affect burn wound healing's response to pulsed electromagnetic waves.
TBSA may significantly affect burn wound healing's response to pulsed electromagnetic waves
Depth of wound may significantly affect burn wound healing's response to pulsed electromagnetic waves
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
burn wound receiving electromagnetic therapy
Arm Type
Experimental
Arm Description
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 of Cairo university hospitals
Intervention Type
Device
Intervention Name(s)
electromagnetic device
Intervention Description
electromagnetic waves for burn wound
Primary Outcome Measure Information:
Title
wound healing rate
Description
tools for assessment of wound area changes before and after treatment
Time Frame
maximum of 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 inflammatory and/or infectious diseases.
Facility Information:
Facility Name
Cairo University
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
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