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Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05907915
Recruitment Status : Completed
First Posted : June 18, 2023
Last Update Posted : June 18, 2023
Sponsor:
Information provided by (Responsible Party):
Noha Mohamed Kamel, Cairo University

Study Description
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Brief Summary:

PURPOSE:

The purpose of the study is to evaluate the effect of (LLLT) on donor site wound healing following skin graft surgery.

BACKGROUND:

The skin graft is a beneficial reconstructive technique for accelerating wound healing .Managing donor site after graft harvesting is very important, and often, patients have more discomfort at the donor site than the recipient burn site itself.Using techniques that accelerate wound healing may enhance patient satisfaction.

Low-level laser therapy (LLLT) has been used in several medical fields, including healing of diabetic, surgical, and pressure ulcers.

Accelerating the healing process and reducing pain during healing are beneficial for the following reasons: faster return to work, lower risk of wound infection, improved quality of life, and possibly reduced need for analgesia.

HYPOTHESES:

It is hypothesized that:

Low level laser therapy has a positive effect on donor site wound healing following skin graft surgery in burned patients.

RESEARCH QUESTION:

Is low level laser therapy has a positive effect on donor site healing following skin graft surgery in burned patients?


Condition or disease Intervention/treatment Phase
Skin Graft Device: low level laser therapy Behavioral: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery
Actual Study Start Date : November 1, 2022
Actual Primary Completion Date : April 30, 2023
Actual Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arms and Interventions
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Arm Intervention/treatment
Experimental: laser group
active low level laser therapy and conventional medical treatment.
 Device: low level laser therapy
They recieved LLLT 1 session daily, 3 session per week for 3 weeks,with the following parameters( 650 nm wavelength, 150 mw power output, 0.25 cm2 radiation area, 0.6 W/cm2 power density, continuous mode, 2 j/ cm2, 90 seconds / cm2) in addition to the conventional medical treatment and traditional wound care (dressing)
Placebo Comparator: placebo group
placebo laser and conventional medical treatment
 Behavioral: placebo
They received placebo laser 1 session daily, 3 session per week for 3 weeks in addition to the conventional medical treatment and traditional wound care (dressing)


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of wound surface area at day 1 post-operative (pre-treatment)(baseline measurement) [ Time Frame: 1 day ]
    Measurement of wound surface area by photography and image J software at day 1

  2. Measurement of wound surface area at day 11 post-operative (post-treatment) [ Time Frame: 11 day ]
    Measurement of wound surface area by photography and image J software at day 11

  3. Measurement of wound surface area at day 21 post-operative (post-treatment) [ Time Frame: 21 day ]
    Measurement of wound surface area by photography and image J software at day 21


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients are both males and females.
  • Their Age will be range between 20-40 years.
  • All patients suffering from third degree burn with TBSA for burn will be ranged from 20% to 35%.
  • All patients undergoing split thickness skin graft surgery.
  • All patients will begin the treatment program from the 1st day post operative
  • All patients enrolled to the study will have their informed consent.
  • All patients have donor sites from the thigh.

Exclusion Criteria:

  • • Patients with associated diseases (Diabetes mellitus, infectious diseases, autoimmune disease) that will interfere with the healing process.

    • Patients taking medication that alter the healing process (e.g., corticosteroids, chemotherapy or radiation.
    • Pregnancy or epilepsy.
    • Elderly patients.
    • Subjects who have photosensitive problems
    • History of trauma or accidental injuries.
    • Skin diseases.
    • History of surgery on particular donor site.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05907915


Locations
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Egypt
Cairo University
Giza, Egypt, 12613
Sponsors and Collaborators
Cairo University
More Information
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Publications:

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Responsible Party: Noha Mohamed Kamel, lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT05907915    
Other Study ID Numbers: P.T.REC/012/003623
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: June 18, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No