Evaluation of the KLOX BioPhotonic WoundGel System in the Treatment of Surgical Wounds

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Clinical Study Evaluating the Safety and Efficacy of the KLOX BioPhotonic WoundGel System When Compared With Silicone Sheets in the Treatment of Surgical Wounds

Conditions
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Surgical Wounds

Intervention / Treatment
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* Device: KLOX BioPhotonic WoundGel System
* Device: Silicone sheets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated written informed consent form Female patients, aged between 18 and 75 years old 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 Fitzpatrick skin type I to IV 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 Patients able to understand, willing and able to comply with all study requirements 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 Females of childbearing potential must not be lactating at Study Screening and agree to use adequate contraceptive method during the Study Exclusion Criteria: Inability to understand the Study and its requirements or to give informed consent Patient has participated in any other clinical study within 3 months prior to Study Screening and throughout the Study duration 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 Current use of anticoagulants such as (but not limited to) warfarin, clopidogrel, enoxaparin or high doses of aspirin (> 162 mg daily) Patient with current alcohol use or actively consuming drugs (addiction) as it may interfere with patient's ability to comply with Study procedures Female patient pregnant, nursing or planning to become pregnant within the next 18 months Patient is a current smoker or has been smoking or using nicotine product(s) in the last three months 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 Patients who are immunocompromised or taking immunosuppressive therapy Any concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the Study investigational device 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 Patients with known hypersensitivity to pain medications Patients with severe elastosis Patients with severe or cystic acne on the area(s) to be treated Presence of a metal stent or implant in the area(s) to be treated 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 Patients anticipating the need for surgery or overnight hospitalization during the course of the Study Patients with history of keloids or hypertrophic scars Patients anticipating sun tanning bed or excessive sun exposure during the Study period Patients with significant breast asymmetry that may result in asymmetrical operative incisions being made on the left and right breasts Patients with breast asymmetry that may result in different post-operative tensions on the wounds of the left and right breasts Patients having had surgery in the area to be incised within one year of Study Screening Patients with tattoos in the areas of incisions Patients with incisions that are actively bleeding Patients with history of irradiated breast(s) in the area(s) to be treated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

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: Treatment with KLOX BioPhotonic WoundGel System<br>One breast will be randomized to be treated with KLOX BioPhotonic WoundGel System. | Device: KLOX BioPhotonic WoundGel System<br>* Patients will then be re-randomized to one of the three comparisons: treatment starting on day 7 post-surgery, treatment starting on Day 21 post-surgery, or two consecutive treatments applied once weekly.<br>|
| Active Comparator: Treatment with silicone sheets<br>The second breast will be randomized to be treated with silicone sheets. | Device: Silicone sheets<br>* Treatment of the surgical wounds with silicone sheets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events, Serious Adverse Events and Device Incidents | Number of patients with adverse events, serious adverse events and device incidents | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Observer Scar Assessment Scale (POSAS) | Assessment of the efficacy of the KLOX BioPhotonic WoundGel System and of Silicone Sheets by the patient and by the investigator via the POSAS | up to 24 weeks | 
| Vancouver Scar Scale (VSS) | Assessment of the efficacy of the KLOX BioPhotonic WoundGel System and of Silicone Sheets by the investigator via the VSS | up to 24 weeks | 
| Efficacy as assessed by blinded experts panel | Assessment of the efficacy of the KLOX BioPhotonic WoundGel System and of Silicone Sheets by a blinded experts committee | up to 24 weeks | 
| Ease of wound management | Patient's self-assessment of ease of wound management by a specific questionnaire | up to 24 weeks |