Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 11/11/2017 |
| Start Date: | December 2012 |
| End Date: | November 2017 |
Doubleblinded, Randomized, Controlled Trial to Study the Effect of Omnilux Light Emitting Diode on Wound Healing Following Lower Extremity Surgical Wounds Left to Heal by Second Intention
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.
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.
Group 2 of this study will receive the LED 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.
Groups 1 and 2 will receive 4 sham light or treatment sessions, respectively (one session
every week for 4 weeks). After these sessions are done, all subjects will continue weekly
follow up visits until the wound is closed, or 3 months after the surgery have passed; which
ever happens first.
One final follow up visit will occur 1 week after the wound closed.
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.
Groups 1 and 2 will receive 4 sham light or treatment sessions, respectively (one session
every week for 4 weeks). After these sessions are done, all subjects will continue weekly
follow up visits until the wound is closed, or 3 months after the surgery have passed; which
ever happens first.
One final follow up visit will occur 1 week after the wound closed.
Inclusion Criteria:
- Surgical defect on the lower extremity left to heal by secondary intention.
- If women of child bearing potential, contraceptive measures should be used
- Maximum size of wound is 5cm x5cm; there is no minimum size for the wound.
Exclusion Criteria:
- History of porphyria photosensitive eruptions, diabetes mellitus, history of venous
insufficiency, known history of peripheral arterial disease (ABI <0.8)
- Use of any ointments or creams containing photosensitizers (coumarins or porphyrins)
should be discontinued for 2 weeks prior
- Use of systemic or local retinoids for the past 6 months.
- Current pregnancy or breastfeeding
- History of metastatic cancer.
We found this trial at
1
site
Miami, Florida 33136
Phone: 305-243-8485
Click here to add this to my saved trials
