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Effects of phototherapy on pressure ulcers

Effects of photobiomodulation on pressure injury stages 2 and 3 clinical controlled randomized blinded study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2s4tpw
Enrollment
Unknown
Registered
2020-01-02
Start date
2020-02-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure ulcer

Interventions

Control group: 10 individuals treated with polyhexanide biguanide 0.1% plus hydrogel, performed once a day, during 15 days. LED group: 10 individuals treated with 0.1% biguanide polyhexanide and appl
Drug
Device
Radiation
E02.774

Sponsors

São Paulo Secretaria da Saúde
Lead Sponsor
Universidade Nove de Julho
Collaborator

Eligibility

Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Participants over 18 years. Both sexes. With pressure injury stages 2 or 3. Length of stay 15 days.

Exclusion criteria

Exclusion criteria: Participants with active neoplasms or palliative care; osteomyelitis in the wound region or with stage 1 or 4 pressure injuries. Deep tissue injury; unclassifiable lesions; complex wounds, necrotic; infected will be excluded. Patients with a history of photosensitivity to photonic therapy or who have significant neurological or psychiatric disorders will also be excluded from the study as it compromises assessments of uncoupling or pain during photobiomodulation

Design outcomes

Primary

MeasureTime frame
Assess pressure injury using the Bates-Jensen Wound Assessment Tool (BWAT). It is expected to find a decrease in the scale score due to the proposed treatment with significance between the control group and the others by at least 5%. Lower scores indicate better healing rate

Secondary

MeasureTime frame
Area and volume of injury will be assessed by digital photographs and specific software;Lesion temperature, with infrared digital thermometer, which does not require direct contact with the lesion;The lesion pH , using reagent strips;Hemoglobin, hematocrit, erythrocyte sedimentation rate, and C-reactive protein by blood tests;Nutritional Risk Screening, used to track cases of hospital malnutrition. The evaluations of this instrument will be performed by the institution's nutritionists.;Therapeutic Intervention Scoring System-28 (TISS-28), an instrument that classifies the severity of patients, allowing the prediction of specific nursing care and resources.

Countries

Brazil

Contacts

Public ContactRita Ferreira

São Paulo Secretaria da Saúde

rcassiadermato@gmail.com+55-11-22815164

Outcome results

None listed

Source: REBEC (via WHO ICTRP)