Clinical trial NCT05907915: Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery
Official title: Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility 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.

Primary outcomes:
measure: Measurement of wound surface area at day 1 post-operative (pre-treatment)(baseline measurement)
timeFrame: 1 day
measure: Measurement of wound surface area at day 11 post-operative (post-treatment)
timeFrame: 11 day
measure: Measurement of wound surface area at day 21 post-operative (post-treatment)
timeFrame: 21 day
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References:
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.
citation: 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.
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.
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.