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

NCT02296697 | Unknown

• 1 other identifier: 140372
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Pressure Ulcer

Keywords

Pressure Ulcer; Low Level Laser Therapy; Dressings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes on clinical evolution of the pressure ulcer 28 days after first intervention

  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

  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.

Study Arms (3)

Low-level laser therapy AlGaInP

ACTIVE COMPARATOR

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; Other: Wound dressing with saline solution

High-frequency therapy with O3 formation

ACTIVE COMPARATOR

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.

Device: High-frequency therapy with O3 formation; Other: Wound dressing with saline solution

Wound dressing with saline solution

PLACEBO COMPARATOR

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

Interventions

Low-level laser therapy AlGaInP 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.

Also known as: Low-level laser therapy AlGaInP wavelength of 660 nm

Low-level laser therapy AlGaInP

High-frequency therapy with O3 formation 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.

Also known as: High-frequency therapy with ozone formation

High-frequency therapy with O3 formation

Wound dressing with saline solution 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; Low-level laser therapy AlGaInP; Wound dressing with saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Bandages; Saline Solution

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Graciele Sbruzzi, Dra

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graciele Sbruzzi, Dra

CONTACT

+55 51 94239420; graciele.sbruzzi@ufrgs.br

Fernanda M Balzan, Dra

CONTACT

+55 51 84281744; fbalzan@hcpa.ufrgs.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: November 20, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

BR (1)