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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05907915
Collaborator
(none)
40
1
2
5.9
6.8

Study Details

Study Description

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
  • Device: low level laser therapy
  • Behavioral: placebo
N/A

Study Design

Study Type:
Interventional
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 :
Nov 1, 2022
Actual Primary Completion Date :
Apr 30, 2023
Actual Study Completion Date :
Apr 30, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Measurement of wound surface area at day 1 post-operative (pre-treatment)(baseline measurement) [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) [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) [21 day]

    Measurement of wound surface area by photography and image J software at day 21

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Cairo University Giza Egypt 12613

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Noha Mohamed Kamel, lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT05907915
Other Study ID Numbers:
  • P.T.REC/012/003623
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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

Study Results

No Results Posted as of Jun 18, 2023