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Completed

NCT Number: NCT05907915

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

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?

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Key information

Conditions

Skin Graft

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, 12613, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Level Laser Therapy

Device

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

Behavioral

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)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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