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Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention

NCT02383056 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-05-23

Study results available
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Summary

The goal of the study is to evaluate the effectiveness of the light-emitting diode (LED) in promoting healing of the wound on lower leg as a result of surgery. Wounds on the lower leg heal more slowly than wounds on the head and neck; they can also remain deep red for six months to one year. Doctors usually allow a lower leg surgical wound to heal by itself, without stitches or other additional treatment. This is because leg wounds do not hold stitches well and stitches could cause other problems. A major drawback of allowing a surgical wound on the lower leg to heal by itself is the long healing time that can often take months. The investigators wish to evaluate if the LED light treatment of the surgical wound will improve the healing of your wound.

In order to test if leg wounds heal faster after treatment with LED, half of the patients in the study will receive the LED (Group 2) and half will not receive treatment with LED but will receive a "sham light" treatment (Group 1). Essentially, a sham light treatment refers to regular light (not LED) exposure for 20 minutes. The sham light comes from the same device as the treatment light (Omnilux machine) however, this light has no anticipated effects on wound healing and is used simply to reduce the amount of bias that sometimes complicates the results of these studies. There is no added risk or benefit for the patients in the control group exposed to the sham light. Both groups will receive the standard care of wounds on the lower extremity.

Conditions

  • Wound

Interventions

DEVICE

Omnilux

Photomodulation irradiated with a 633 +/- 3 mm light source for 20 minutes (105 mW/cm, 126 J/cm)

DEVICE

Omnilux Sham

Sham light instead of phototherapy from the same light device

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Keyvan Nouri, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02383056 on ClinicalTrials.gov