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

NCT ID: NCT02296697

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-12-31

Brief Summary

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).

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.

Conditions

Pressure Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Low-level laser therapy AlGaInP

Intervention Type: DEVICE

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.

Wound dressing with saline solution

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

High-frequency therapy with O3 formation

Intervention Type: DEVICE

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.

Wound dressing with saline solution

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

Wound dressing with saline solution

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Low-level laser therapy AlGaInP wavelength of 660 nm; High-frequency therapy with ozone formation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Graciele Sbruzzi, Dra

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Graciele Sbruzzi, Dra

Role: CONTACT

graciele.sbruzzi@ufrgs.br

+55 51 94239420

Fernanda M Balzan, Dra

Role: CONTACT

fbalzan@hcpa.ufrgs.br

+55 51 84281744

Facility Contacts

Graciele Sbruzzi, Dra

Role: primary

graciele.sbruzzi@ufrgs.br

0555194239420

Other Identifiers

140372

Identifier Type: -

Identifier Source: org_study_id