Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries

NCT04361773 | Unknown Phase 1

• 1 other identifier: TraumaSoftTissue
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change of the wound healing process using the BATES-JENSEN scale

  Evaluation of the healing process of soft tissue injuries in lower limbs associated with tibial fractures caused by high-energy trauma using the variation in the Bates Jensen Wound Assessment Tool scale score. The current version of BWAT contains 13 items that measure size, depth, borders, detachment, type and amount of necrotic tissue, type and amount of exudate, edema and hardening of the peripheral tissue, skin color around the wound, granulation tissue and epithelialization. The measurement scale is of the Likert type, with five points, where 1 indicates the best condition of the wound and 5, the worst condition. The total score is obtained with the sum of all items and can vary from 13 to 65 points, with the highest scores indicating the worst wound conditions. The items size, depth, edges and detachment should be scored as zero when the lesions are healed. The instrument contains two additional items - location and shape - that are not part of the total score.

  Baseline and through study completion, an average of 1 month.

Secondary Outcomes (8)

• Change in Pain Intensity Through VAS

  Baseline and through study completion, an average of 1 month.

• Consumption of painkillers

  Baseline and through study completion, an average of 1 month.

• Change in serum evolution of inflammatory markers

  Baseline, every three days and through study completion, an average of 1 month.

• Change in Lesion Area Measurement

  Baseline and through study completion, an average of 1 month.

• Time needed for liberation for definitive surgery

  Baseline and through study completion, an average of 1 month.

Study Arms (2)

Photobiomodulation group

ACTIVE COMPARATOR

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.

Radiation: Photobiomodulation

Sham group

SHAM COMPARATOR

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.

Other: Sham Photobiomodulation

Interventions

Photobiomodulation RADIATION

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

Photobiomodulation group

Sham Photobiomodulation 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.

Sham group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Soft Tissue Injuries

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Researchers who will carry out the application of PBM will not carry out any type of evaluation. The evaluations (initial and after application of the FBM) will be made by the field researchers, who will not be informed of the group in which each participant is allocated. Participants will not be aware of whether or not they have received PBM, as the applicator researchers will position the equipment at the irradiation sites in all participants, cover the limb with fabric that does not allow visualization, and will only activate the light when and where provided in the specific experimental group. A sound recorded on a cell phone will be played when the participant is allocated to the sham group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: May 30, 2020
• Primary Completion: May 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-04