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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Skin Graft

Treatments

Device: low level laser therapy
Behavioral: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05907915
P.T.REC/012/003623

Details and patient eligibility

About

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?

Enrollment

40 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

laser group
Experimental group
Description:
active low level laser therapy and conventional medical treatment.
Treatment:
Device: low level laser therapy
placebo group
Placebo Comparator group
Description:
placebo laser and conventional medical treatment
Treatment:
Behavioral: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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