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Prediction Rules for Low Level Laser on Burn Wounds

Primary Purpose

Burn Wound, Clinical Prediction Rules

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

low level laser therapy

About this trial

This is an interventional treatment trial for Burn Wound

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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 inﬂammatory and/or infectious diseases.

Sites / Locations

Cairo universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

burn wound receiving low level laser therapy

Arm Description

Outcomes

Primary Outcome Measures

reduced wound surface area

measure of wound surface area using manual tracing method before and after application of treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT05404191

First Posted

May 3, 2022

Last Updated

January 9, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05404191

Brief Title

Prediction Rules for Low Level Laser on Burn Wounds

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

January 15, 2023 (Anticipated)

Study Completion Date

January 15, 2023 (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

Studies a U.S. FDA-regulated Device Product

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 low level laser therapy in burn patients

Detailed Description

It will be hypothesized that Age may significantly affect burn wound healing's response to low level laser therapy. TBSA may significantly affect burn wound healing's response to low level laser therapy. Depth of wound may significantly affect burn wound healing's response to low level laser therapy. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn Wound, Clinical Prediction Rules

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

60 adult of both sexes will participate in this study selected from burn unit of AHMED ORABI hospital, Their ages range from 10 to 50 years, TBSA more than 15%, partial thickness burn depth.

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

burn wound receiving low level laser therapy

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

low level laser therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

reduced wound surface area

Description

measure of wound surface area using manual tracing method before and after application of 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

Eligibility Criteria

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 inﬂammatory and/or infectious diseases.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed M. nagy

Phone

00201285237368

nagypt@gmail.com

Facility Information:

Facility Name

Cairo university

City

Giza

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Mohamed Nagy

Phone

00201285237368

amnagy@msa.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Prediction Rules for Low Level Laser on Burn Wounds

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