Prediction Rules for Low Level Laser on Burn Wounds

Burn Wound Clinical Trial

Official title:

DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF LOW LEVEL LASER ON BURN WOUND HEALING

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404191
• Other study ID #: P.T.REC/012/003532
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: January 2023
• Source: Cairo University
• Contact: Ahmed M. nagy
• Phone: 00201285237368
• Email: nagypt[@]gmail.com
• Is FDA regulated: No
• 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 low level laser therapy in burn patients

Description:

It will be hypothesized that

1. Age may significantly affect burn wound healing's response to low level laser therapy.

2. TBSA may significantly affect burn wound healing's response to low level laser therapy.

3. Depth of wound may significantly affect burn wound healing's response to low level laser therapy.

4. Wound healing stage may significantly affect burn wound healing's response to low level laser therapy. 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.

Low level laser therapy will be performed for 30 min 3 times per week for 8 weeks on the wound area.

Wound area was irradiated by a red 655 nm light, 150 mW, 2 J/cm2 at the bed of the wound.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• 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 test

Exclusion Criteria:

• Diabetic patients.

• Burn wound with skin graft

• Infected wounds

• Patients receiving immunosuppressive drugs.

• Patients receiving irradiation or chemotherapy.

• Chronic circulatory diseases

• Severe associated injury with burn.

• Associated co-morbidities, such as neurological diseases, malnutrition, and other in?ammatory and/or infectious diseases.

Related Conditions & MeSH terms

• Burn Wound
• Burns
• Wounds and Injuries

Intervention

Device:
• low level laser therapy
Low level laser therapy will be performed for 30 min 3 times per week for 8 weeks on the wound area. Wound area was irradiated by a red 655 nm light, 150 mW, 2 J/cm2 at the bed of the 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	reduced wound surface area	measure of wound surface area using manual tracing method before and after application of treatment	maximum of 6 weeks