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Low Intensity Laser Therapy in Skin Injury Caused by the Use of Orthopedic Cage

Photobiomodulation in Cutaneous Lesion Caused by the Use of Circular External Fixator: Clinical Study, Placebo Controlled and Randomized

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2xc5vr
Enrollment
Unknown
Registered
2019-11-13
Start date
2019-09-30
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

Fracture Ilizarov Technique

Interventions

Photobiomodulation group (GFBM): 20 participants will receive dressing with 0.9% saline plus essential fatty acids and red laser irradiation at 4 points per lesion, with a wavelength of 660 nm, beam a
Drug
Device
Radiation
E02.594.540

Sponsors

Clínica Dr Ayres Fernando Rodrigues
Lead Sponsor
Associação Educacional Nove de Julho
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Participants over 18 years of age, both genders; with preserved cognition; using circular external fixator due to bone discrepancy; pseudarthrosis or bone deformity.

Exclusion criteria

Exclusion criteria: Participants with active neoplasms; palliative care; osteomyelitis; infected skin lesion; decompensated diabetics; or participation in another concomitant clinical trial; aged above 70 years or younger than 18 years.

Design outcomes

Primary

MeasureTime frame
To evaluate the skin wound caused by the use of the external fixator using the Bates-Jensen Wound Assessment Tool. It is expected to find a decrease in the scale score as a function of the proposed treatment, with significance between the controlled group of at least 5%;lower scores indicate better healing rate.;Evaluate the size and depth with numerical ruler, wound edge characteristics, tissue type and image exudate; surrounding skin coloration, peripheral edema. It is expected to find a decrease in the scale score as a function of the proposed treatment, with significance between the controlled group of at least 5%; lower scores indicate better healing rate.—

Secondary

MeasureTime frame
To evaluate the pain caused by the use of the external fixator through the visual analog scale (VAS). It is expected to find a decrease in the scale score as a function of the proposed treatment, with significance between the controlled group of at least 5%;lower scores indicate better healing rate. ;To evaluate the temperature and pH of the lesion caused by the use of the external fixator by means of digital infrared thermometer and reagent strips, respectively. It is expected to find temperature decrease and pH regulation, with significance between the controlled group of at least 5%;lower scores indicate better healing rate.—

Countries

Brazil

Contacts

Public ContactVirgínia Rodrigues

Associação Educacional Nove de Julho

virginiammr@yahoo.com.br551133859222

Outcome results

None listed

Source: REBEC (via WHO ICTRP)