Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Graciele Sbruzzi, Dra | Contact | +55 51 94239420 | graciele.sbruzzi@ufrgs.br | |
| Fernanda M Balzan, Dra | Contact | +55 51 84281744 | fbalzan@hcpa.ufrgs.br |
| Name | Affiliation | Role |
|---|---|---|
| Graciele Sbruzzi, Dra | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035903 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001458 | Bandages |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
| 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. |
|
| 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. |
| D004364 |
| Pharmaceutical Preparations |