Assessment Of Infrared Photobiotherapy for Improved Wound Healing

Study Overview
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Brief Summary
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The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can reduce pain and/or improve wound healing in patients with an acute traumatic injury to the upper extremity (wrist, forearm, or elbow).

Detailed Description
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This is a prospective, two group, controlled study using random assignment. All eligible patients will be randomly assigned to one of two groups: the control group (usual care) or the experimental group (usual care plus LLLT). We plan to enroll 50 subjects in this study: 25 subjects will be randomly assigned to the LLLT group and 25 to the usual care group. All subjects will be recruited within one to two days prior to hospital discharge or at the time of their first postoperative clinic visit. No subjects will be recruited while sedated or receiving intravenous pain medication.

Conditions
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Wound Healing

Intervention / Treatment
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* Device: Low Level Laser Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 and < 85 years Acute traumatic injury of an upper extremity (wrist, forearm, or elbow) Currently resides within 100 miles of UMC Exclusion Criteria: Pregnant Pacemaker Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics) Two or more cardiac risk factors Intraoperative complications Wound infection Open Wound

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low Level Laser Therapy | Device: Low Level Laser Therapy<br>* Low Level Laser Therapy on Wound<br>|
| No Intervention: 2<br>No Laser Therapy. Outcome Measures the same. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Traumatic Injury (ATI) patients treated with LLLT will experience a |  | baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline | 
| Decrease in post-operative pain as measured by the FACES Pain Rating Scale |  | baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline | 
| Reduction in amount of pain medication needed to control pain |  | baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline | 
| Improvement in wound healing as measured by serial photographs of wound appearance and rate of wound healing. |  | baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional factors that may influence pain (type of injury, perioperative blood loss, smoking) |  | baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline | 
| Improvement in Quality of Life as measured by the SF-36 |  | baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline |