Evaluation of the KLOX BioPhotonic WoundGel System in the Treatment of Surgical Wounds
Evaluation of the KLOX BioPhotonic WoundGel System in the Treatment of Surgical Wounds
This is a multicenter, randomized, prospective, controlled study in patients having bilateral
 breast reduction. Objectives of the study are to evaluate the safety and efficacy of the KLOX
 BioPhotonic WoundGel System compared with the ones of Silicone Sheets in the treatment of
 surgical wounds.
Inclusion Criteria:

 1. Signed and dated written informed consent form

 2. Female patients, aged between 18 and 75 years old

 3. Good general health, stable weight, free of systemic diseases such as diabetes,
 arthritis, HIV infection or genetic disorder that could influence the outcome of the
 treatment

 4. Fitzpatrick skin type I to IV

 5. Patients scheduled to go through bilateral breast reduction and expected to have newly
 formed post-surgery breast incisions of comparable length, located on comparable skin
 area

 6. Patients able to understand, willing and able to comply with all study requirements

 7. Patients must either be incapable of reproduction, or taking acceptable measures to
 prevent pregnancy and have a negative pregnancy test prior to participation in the
 Study

 8. Females of childbearing potential must not be lactating at Study Screening and agree
 to use adequate contraceptive method during the Study

 Exclusion Criteria:

 1. Inability to understand the Study and its requirements or to give informed consent

 2. Patient has participated in any other clinical study within 3 months prior to Study
 Screening and throughout the Study duration

 3. Systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that
 might interfere with healing within the last three months prior to Study Screening and
 throughout the Study duration

 4. Current use of anticoagulants such as (but not limited to) warfarin, clopidogrel,
 enoxaparin or high doses of aspirin (> 162 mg daily)

 5. Patient with current alcohol use or actively consuming drugs (addiction) as it may
 interfere with patient's ability to comply with Study procedures

 6. Female patient pregnant, nursing or planning to become pregnant within the next 18
 months

 7. Patient is a current smoker or has been smoking or using nicotine product(s) in the
 last three months

 8. Patient with known photosensitivity, taking drug(s) to treat photosensitivity, with
 concurrent disease (such as porphyria) or drug(s) (such as methotrexate or
 chloroquine) known to induce severe photosensitivity of the skin

 9. Patients who are immunocompromised or taking immunosuppressive therapy

 10. Any concurrent therapy that, in the investigator's opinion, would interfere with the
 evaluation of the safety or efficacy of the Study investigational device

 11. Patient has ongoing malignant disease of any type, active systemic, local skin
 infection or disease, autoimmune disease or any significant chronic disease which, in
 the opinion of the investigator, might interfere with the evaluation of the Study
 objectives or would result in non-compliance with the Study protocol

 12. Patients with known hypersensitivity to pain medications

 13. Patients with severe elastosis

 14. Patients with severe or cystic acne on the area(s) to be treated

 15. Presence of a metal stent or implant in the area(s) to be treated

 16. Patients with derma resurfacing procedures or non-invasive skin-tightening procedures
 including medium/deep chemical peeling, microdermabrasion, laser therapy or
 prescription level glycolic acid treatment to the treatment area(s) within three
 months prior to Study Screening or during the Study

 17. Patients anticipating the need for surgery or overnight hospitalization during the
 course of the Study

 18. Patients with history of keloids or hypertrophic scars

 19. Patients anticipating sun tanning bed or excessive sun exposure during the Study
 period

 20. Patients with significant breast asymmetry that may result in asymmetrical operative
 incisions being made on the left and right breasts

 21. Patients with breast asymmetry that may result in different post-operative tensions on
 the wounds of the left and right breasts

 22. Patients having had surgery in the area to be incised within one year of Study
 Screening

 23. Patients with tattoos in the areas of incisions

 24. Patients with incisions that are actively bleeding

 25. Patients with history of irradiated breast(s) in the area(s) to be treated.