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

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Pressure Ulcer

Treatments: Device: Low-level laser therapy AlGaInP; Other: Wound dressing with saline solution; Device: High-frequency therapy with O3 formation

Study type: Interventional

Funder types: Other

Identifiers

NCT02296697

140372

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

Low-level laser therapy AlGaInP

Active Comparator group

Description:

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.

Treatment:

Device: Low-level laser therapy AlGaInP

Other: Wound dressing with saline solution

High-frequency therapy with O3 formation

Active Comparator group

Description:

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.

Treatment:

Device: High-frequency therapy with O3 formation

Other: Wound dressing with saline solution

Wound dressing with saline solution

Placebo Comparator group

Description:

Wound dressing with hygiene of the pressure ulcer with warm saline and after applying the bandage will be held will be held.

Treatment:

Other: Wound dressing with saline solution