Pressure Ulcer
Conditions
Keywords
Pressure Ulcer, Low Level Laser Therapy, Dressings
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.
Interventions
DEVICELow-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.
DEVICEHigh-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.
OTHERWound 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.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on pressure ulcer 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
Countries
Brazil
Contacts
Primary ContactGraciele Sbruzzi, Dra
Backup ContactFernanda M Balzan, Dra
Outcome results
None listed