Low-level Laser Therapy Versus High Frequency on Pressure Ulcers Treatment

Comparison Between the Effects of Low-level Laser Therapy, High Frequency and Wound Dressing on Pressure Ulcers Treatment: a Clinical Randomized Trial

Patients admitted in the Emergency Service that have pressure ulcers will be selected by eligibility criteria and randomized into three groups according to the adopted therapy: wound dressing (CG); wound dressing + high-frequency generator group (GAF); and wound dressing + low-level laser therapy group (GLBP).

Study Overview

• Status: Unknown
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Low-level laser therapy AlGaInP; Other: Wound dressing with saline solution; Device: High-frequency therapy with O3 formation

Detailed Description

Wound dressing is considered the standard treatment for pressure ulcers, however, despite its proven efficacy, it's a long-term healing process. Among Physiotherapy resources available for pressure ulcers treatment, the most used are low-level laser therapy and high-frequency generator. Even though the individual effects of both are evidenced on literature, there are no randomized clinical trials evidencing the effects of low-level laser therapy and high-frequency generator in comparison to wound dressing on pressure ulcers treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Graciele Sbruzzi, Dra; Phone Number: +55 51 94239420; Email: graciele.sbruzzi@ufrgs.br
• Study Contact Backup: Name: Fernanda M Balzan, Dra; Phone Number: +55 51 84281744; Email: fbalzan@hcpa.ufrgs.br

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Graciele Sbruzzi, Dra; Phone Number: 0555194239420; Email: graciele.sbruzzi@ufrgs.br
      • Sub-Investigator: Fernanda M Balzan, Dra
      • Principal Investigator: Graciele Sbruzzi, Dra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pressure ulcers with rate II or III;
• Not receiving pressure ulcer treatment.

Exclusion Criteria:

• Presence of necrotic tissue needing debridement
• Pregnancy
• Discomfort during treatment
• Pressure ulcers with area bigger than 30cm2
• Extensive tunneling
• Diabetes mellitus (DM)
• Severe metabolic disease
• Use of corticosteroids or vasopressors
• Immunosuppression
• Pacemaker
• Neoplasia
• Hemorrhage
• Sensibility disorders
• Metalic device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-level laser therapy AlGaInP; AlGaInP 660 nm laser and dose of 6 J / cm 2 with point application on the edges of the lesion and sweep up application in the center.	Device: Low-level laser therapy AlGaInP; Pressure ulcers will be treated with AlGaInP 660 nm laser, wich will be used once a day, five days per week, dosed with 6 J/cm2. Laser therapy is applied punctually in each 1cm2 of the ulcer.; Other Names: Low-level laser therapy AlGaInP wavelength of 660 nm; Other: Wound dressing with saline solution; Wound dressing will be done daily on patients from the three groups during the study period. On patients who will receive laser therapy and high frequency, the pressure ulcer will be sanitized with worm saline solution in order to clean the wound. This cleaning will be done before and after the interventions.
Active Comparator: High-frequency therapy with O3 formation; High frequency generator, spherical electrode. Direct spark technique will be used, in which the electrode is positioned millimeters away from the skin of the patient, causing the formation of sparks, with increasing intensity up to 80 to 100% for ozone formation.	Other: Wound dressing with saline solution; Wound dressing will be done daily on patients from the three groups during the study period. On patients who will receive laser therapy and high frequency, the pressure ulcer will be sanitized with worm saline solution in order to clean the wound. This cleaning will be done before and after the interventions.; Device: High-frequency therapy with O3 formation; High-frequency laser therapy will be applied with spherical electrode, wich contains neon gas inside, from a short distance from the pressure ulcer. The application will last 15 minutes, with increasing intensity from 80 to 100% for ozone formation, once a day, five days per week.; Other Names: High-frequency therapy with ozone formation
Placebo Comparator: Wound dressing with saline solution; Wound dressing with hygiene of the pressure ulcer with warm saline and after applying the bandage will be held will be held.	Other: Wound dressing with saline solution; Wound dressing will be done daily on patients from the three groups during the study period. On patients who will receive laser therapy and high frequency, the pressure ulcer will be sanitized with worm saline solution in order to clean the wound. This cleaning will be done before and after the interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on pressure ulcer area 28 days after first intervention	Evaluated through absolute (mm ²) reduction according to baseline. The participants will be followed while hospitalized, and outcome measure will be assessed at 7th, 14th, 21st and 28th day after the study randomization.	Patients will be evaluated on the 7th, 14th, 21st and 28th day after randomized, while hospitalized. If discharge before, follow up will be done untill the last day of hospitalization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on clinical evolution of the pressure ulcer 28 days after first intervention	Clinical evolution of UP through PUSH score. The participants will be followed while hospitalized, and outcome measure will be assessed at 7th, 14th, 21st and 28th day after the study randomization.	Patients will be evaluated on the 7th, 14th, 21st and 28th day after randomized, while hospitalized. If discharge before, follow up will be done untill the last day of hospitalization.
Changes on pressure ulcer relative area 28 days after first intervention	Evaluated through relative (%) reduction according to baseline. The participants will be followed while hospitalized, and outcome measure will be assessed at 7th, 14th, 21st and 28th day after the study randomization.	Patients will be evaluated on the 7th, 14th, 21st and 28th day after randomized, while hospitalized. If discharge before, follow up will be done untill the last day of hospitalization.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Graciele Sbruzzi, Dra, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Estimate): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Dressings; Pressure Ulcer; Low Level Laser Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: 140372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided