Clinical trial NCT04361773: Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries
Official title: Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries: Study Protocol for a Double-Blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Soft Tissue Injuries
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) is indicated as an adjuvant treatment to accelerate wound healing, however, there is still a lack of evidence regarding its effect on traumatic soft tissue injuries. This project aims to evaluate the effects of the application of PBM in the resolution of complex soft tissue injuries of traumatic origin associated with tibial fractures. 84 adult individuals, aged between 18 and 60 years, hospitalized with tibial fractures awaiting resolution of soft tissue injuries will be included to undergo definitive surgery. The subjects will be randomized in two groups: PBM (treated with a device with 144 LED emitting diodes at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes) and Sham (simulation of the LED application, with a device with characteristics identical to that of the PBM group, for the same period of time). Subjects will be treated daily until release for surgery. The primary outcome will be the assessment of the wound healing process using the BATES-JENSEN scale. Secondary outcomes will be: pain intensity; consumption of analgesic drugs; serum evolution of inflammatory markers C-reactive protein and creatine kinase, measurement of the lesion area, time needed for release for definitive surgery, presence of infection, and the cost-effectiveness of PBM. The evaluations will be carried out before the beginning of the intervention and daily until the participant is considered ready for surgery (which will be considered the end of the experimental period). Data will be analyzed statistically considering a significance level of 5%.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change of the wound healing process using the BATES-JENSEN scale
timeFrame: Baseline and through study completion, an average of 1 month.
Secondary outcomes:
measure: Change in Pain Intensity Through VAS
timeFrame: Baseline and through study completion, an average of 1 month.
measure: Consumption of painkillers
timeFrame: Baseline and through study completion, an average of 1 month.
measure: Change in serum evolution of inflammatory markers
timeFrame: Baseline, every three days and through study completion, an average of 1 month.
measure: Change in Lesion Area Measurement
timeFrame: Baseline and through study completion, an average of 1 month.
measure: Time needed for liberation for definitive surgery
timeFrame: Baseline and through study completion, an average of 1 month.
measure: Presence of Infection
timeFrame: Baseline and through study completion, an average of 1 month.
measure: Cost effectiveness of Photobiomodulation
timeFrame: Baseline and through study completion, an average of 1 month.
measure: Change in Peripheral Perfusion through Clinical Evaluation
timeFrame: Baseline and through study completion, an average of 1 month.
Other outcomes:
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