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

NCT05907915 | Completed

• 1 other identifier: P.T.REC/012/003623
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Skin Graft

Outcome Measures

Primary Outcomes (3)

• Measurement of wound surface area at day 1 post-operative (pre-treatment)(baseline measurement)

  Measurement of wound surface area by photography and image J software at day 1

  1 day

• Measurement of wound surface area at day 11 post-operative (post-treatment)

  Measurement of wound surface area by photography and image J software at day 11

  11 day

• Measurement of wound surface area at day 21 post-operative (post-treatment)

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

  21 day

Study Arms (2)

laser group

EXPERIMENTAL

active low level laser therapy and conventional medical treatment.

Device: low level laser therapy

placebo group

PLACEBO COMPARATOR

placebo laser and conventional medical treatment

Behavioral: placebo

Interventions

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)

laser group

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)

placebo group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, 12613, Egypt

Location

Related Publications (4)

• Vaghardoost R, Momeni M, Kazemikhoo N, Mokmeli S, Dahmardehei M, Ansari F, Nilforoushzadeh MA, Sabr Joo P, Mey Abadi S, Naderi Gharagheshlagh S, Sassani S. Effect of low-level laser therapy on the healing process of donor site in patients with grade 3 burn ulcer after skin graft surgery (a randomized clinical trial). Lasers Med Sci. 2018 Apr;33(3):603-607. doi: 10.1007/s10103-017-2430-4. Epub 2018 Jan 24.

  PMID: 29368069 BACKGROUND

• Assis L, Moretti AI, Abrahao TB, Cury V, Souza HP, Hamblin MR, Parizotto NA. Low-level laser therapy (808 nm) reduces inflammatory response and oxidative stress in rat tibialis anterior muscle after cryolesion. Lasers Surg Med. 2012 Nov;44(9):726-35. doi: 10.1002/lsm.22077. Epub 2012 Sep 21.

  PMID: 23001637 BACKGROUND

• Huang J, Chen J, Xiong S, Huang J, Liu Z. The effect of low-level laser therapy on diabetic foot ulcers: A meta-analysis of randomised controlled trials. Int Wound J. 2021 Dec;18(6):763-776. doi: 10.1111/iwj.13577. Epub 2021 Mar 9.

  PMID: 33751853 BACKGROUND

• Voineskos SH, Ayeni OA, McKnight L, Thoma A. Systematic review of skin graft donor-site dressings. Plast Reconstr Surg. 2009 Jul;124(1):298-306. doi: 10.1097/PRS.0b013e3181a8072f.

  PMID: 19568092 BACKGROUND

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 18, 2023
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 18, 2023

Record last verified: 2022-12

Locations

EG (1)