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

NCT ID: NCT02383056

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2017-11-30

Brief 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.

Detailed Description

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.

Conditions

Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham Group (Group 1)

This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes

Group Type: SHAM_COMPARATOR

Omnilux Sham

Intervention Type: DEVICE

Sham light instead of phototherapy from the same light device

Treatment group (Group 2)

This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes

Group Type: EXPERIMENTAL

Omnilux

Intervention Type: DEVICE

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

Interventions

Omnilux

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

Intervention Type: DEVICE

Omnilux Sham

Sham light instead of phototherapy from the same light device

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Keyvan Nouri

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keyvan Nouri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20120475

Identifier Type: -

Identifier Source: org_study_id