Prediction Rules for Low Level Laser on Burn Wounds

January 9, 2023 updated by: ahmed mohamed nagy, Cairo University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: burn wound receiving low level laser therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduced wound surface area
Time Frame: maximum of 6 weeks
measure of wound surface area using manual tracing method before and after application of treatment
maximum of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Anticipated)

January 15, 2023

Study Completion (Anticipated)

January 15, 2023

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003532

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burn Wound

Clinical Trials on low level laser therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe