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

Skin Graft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05907915
• Other study ID #: P.T.REC/012/003623
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: December 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Graft

Intervention

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)

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)

Locations

Country	Name	City	State
Egypt	Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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