Prediction Rules for Low Level Laser on Burn Wounds

NCT ID: NCT05404191

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-01-15

Brief Summary

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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

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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.

Conditions

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Burn Wound Clinical Prediction Rules

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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burn wound receiving low level laser therapy

Group Type EXPERIMENTAL

low level laser therapy

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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ahmed mohamed nagy

lecturer of physical therapy for surgery- Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed M. nagy

Role: CONTACT

00201285237368

Facility Contacts

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Ahmed Mohamed Nagy

Role: primary

00201285237368

Other Identifiers

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P.T.REC/012/003532

Identifier Type: -

Identifier Source: org_study_id

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