Prediction Rules for Low Level Laser on Burn Wounds | NCT05404191

Studies
Prediction Rules for Low Level Laser on Burn Wounds

NCT05404191

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 10, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Burn Wound
Clinical Prediction Rules

Interventions

low level laser therapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Jan 15, 2023Estimated

Completion Date

Jan 15, 2023Estimated

First Submitted Date

May 3, 2022

First Submission Date that Met QC Criteria

Jun 1, 2022

First Posted Date

Jun 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2023

Last Update Posted Date

Jan 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ahmed mohamed nagy, lecturer of physical therapy for surgery- Cairo university, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
burn wound receiving low level laser therapy	Experimental		Device: low level laser therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low level laser therapy	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed M. nagy	Contact	00201285237368		nagypt@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo university	Recruiting	Giza			Egypt

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D028022	Low-Level Light Therapy

Ancestor Terms

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy

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