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

Not Applicable

Completed

• Conditions: Skin Graft
• Interventions: Behavioral: placebo; Device: low level laser therapy

• Registration Number: NCT05907915
• Lead Sponsor: Cairo University

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2022-12
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-14
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	placebo laser and conventional medical treatment
laser group	low level laser therapy	active low level laser therapy and conventional medical treatment.

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt