Status:
UNKNOWN
Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries
Lead Sponsor:
University of Nove de Julho
Conditions:
Soft Tissue Injuries
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Soft tissue injuries are directly related to the energy of the trauma and its repair is the main factor for bone healing and the recovery of the function of the affected limb. Photobiomodulation (PBM)...
Eligibility Criteria
Inclusion
- Adult individuals of both sexes, aged between 18 and 60 years;
- Interned in the Orthopedics and Infirmary Emergency Room of the Surgical Clinic of Conjunto Hospitalar do Mandaqui;
- Victims of high-energy trauma in the lower limbs with sufficient soft tissue injury to make primary closure unfeasible or definitive treatment of injuries in the initial care associated with tibial fracture.
Exclusion
- Diagnosis of chronic systemic diseases (renal failure, diabetes mellitus, hypertension, peripheral vascular insufficiency);
- Allergy to cefazolin and gentamicin;
- Uncontrollable active bleeding;
- Occlusive arteriopathies;
- Compartmental syndrome;
- Necrosis in the area of neurovascular injury with sensory deficit at the injury site;
- History of previous surgeries on the affected limb;
- Local or systemic changes that contraindicate surgical intervention or hinder the postoperative period;
- Smoking;
- Photo sensitivity history;
- Neurological and psychiatric disorders;
- Use of anti-inflammatory drugs in the last 15 days prior to the trauma;
- Pregnant women.
Key Trial Info
Start Date :
May 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04361773
Start Date
May 30 2020
End Date
December 30 2021
Last Update
April 24 2020
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