Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries

NCT ID: NCT04361773

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-30
• Study Completion Date: 2021-12-30

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%.

Conditions

Soft Tissue Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Photobiomodulation group

In this group, PBM will be applied daily using LED devices until the lesion presents healthy granulation tissue, absence of necrosis and purulent secretion and, therefore, is suitable for primary closure, closure by flap or graft or for healing by second intention. At this point, the protocol will be finalized.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation

Intervention Type: RADIATION

Treatment with a device with 144 light emitting diodes (LEDs) at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes.

Sham group

Sham group participants will receive the application of the disconnected device, for the same period. The characteristic sound of the device will be activated by means of recording.

Group Type: SHAM_COMPARATOR

Sham Photobiomodulation

Intervention Type: OTHER

Simulation of the LED application, with a device with external characteristics identical to that of the PBM group, for the same period of time.

Interventions

Photobiomodulation

Treatment with a device with 144 light emitting diodes (LEDs) at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes.

Intervention Type: RADIATION

Sham Photobiomodulation

Simulation of the LED application, with a device with external characteristics identical to that of the PBM group, for the same period of time.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

TraumaSoftTissue

Identifier Type: -

Identifier Source: org_study_id