Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries

April 22, 2020 updated by: Sandra Kalil Bussadori, University of Nove de Julho

Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries: Study Protocol for a Double-Blind, Randomized, Controlled Trial

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%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Radiation: Photobiomodulation
Treatment with a device with 144 light emitting diodes (LEDs) at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes.
Sham Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of the wound healing process using the BATES-JENSEN scale
Time Frame: Baseline and through study completion, an average of 1 month.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity Through VAS
Time Frame: Baseline and through study completion, an average of 1 month.
Pain will be assessed by field researchers by applying the visual analogue pain scale (VAS). This scale is represented by a 10 cm line, with the phrases "no pain" and "unbearable pain" at its ends.
Baseline and through study completion, an average of 1 month.
Consumption of painkillers
Time Frame: Baseline and through study completion, an average of 1 month.
The type, dosage and frequency of analgesic consumption will be checked and recorded daily during the medical visit by the field team responsible for the daily medical visit. The results will be passed on to the main researcher for storage, tabulation and interpretation.
Baseline and through study completion, an average of 1 month.
Change in serum evolution of inflammatory markers
Time Frame: Baseline, every three days and through study completion, an average of 1 month.
For laboratory evaluation of the evolution of the inflammatory process and muscle damage, the following tests will be collected: C-reactive protein (CRP), Creatinophosphokinase (CPK), serum urea, creatinine, blood count and coagulogram. These exams will be collected at the time of admission, every three days and when the soft parts are resolved.
Baseline, every three days and through study completion, an average of 1 month.
Change in Lesion Area Measurement
Time Frame: Baseline and through study completion, an average of 1 month.
The wounds will be photographed along with a cut of graph paper using the camera of the iPhone 8 mobile device, to allow the calibration of the measurement application. The photos will be taken by the doctors who will visit the patient daily at the patient's bed and pass them on to the main researcher. The images will be stored and later evaluated with the aid of the Image J® application, a public domain Java image processor and analyzer, developed by Wayne Rasband of the Research Services Branch, National Institute of Mental Health, Bethesda, Maryland.
Baseline and through study completion, an average of 1 month.
Time needed for liberation for definitive surgery
Time Frame: Baseline and through study completion, an average of 1 month.
Each lesion will be considered solved when it presents healthy granulation tissue, without necrosis or purulent secretion and is, therefore, suitable for primary closure, flap or graft closure or apt to choose healing by second intention. At this point, the protocol will be finalized and this data will be added to the study participant's medical record.
Baseline and through study completion, an average of 1 month.
Presence of Infection
Time Frame: Baseline and through study completion, an average of 1 month.
Field researchers will collect information regarding the patient's temperature, blood pressure and heart rate every 24 hours. In addition, the wound will be evaluated for the presence of secretion, necrosis, odor and color. If the wound shows signs of infection (purulent secretion, foul odor, areas of superficial or deep necrosis, accompanied or not by systemic signs such as fever, a fall in general condition, lack of appetite), surgical cleaning of the wound will be indicated, and at this moment, collections of samples for culture and photographs before and after surgical debridement will be carried out by field researchers. The patient will be excluded from the study.
Baseline and through study completion, an average of 1 month.
Cost effectiveness of Photobiomodulation
Time Frame: Baseline and through study completion, an average of 1 month.
The cost-effectiveness establishes whether or not a treatment should be implemented as a therapeutic measure, being calculated by the difference between the cost of two interventions proposed as treatment divided by the difference between its consequences. For the evaluation of the cost-effectiveness of photobiomodulation, the "reduction in the score of the Bates Jensen scale" will be considered as the outcome.
Baseline and through study completion, an average of 1 month.
Change in Peripheral Perfusion through Clinical Evaluation
Time Frame: Baseline and through study completion, an average of 1 month.
The peripheral perfusion of the affected limb will also be evaluated clinically by two doctors, through palpation of the distal pulses (pedicle and posterior tibial), pain and passive extension of the fingers (to clinically assess the occurrence of compartment syndrome) capillary filling time, limb, granulation of the wound, occurrence of superficial or deep necrosis. In case of vascular involvement of the limb, joint assessment with the vascular surgery service will be requested and the case will be excluded from the study.
Baseline and through study completion, an average of 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TraumaSoftTissue

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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