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

NCT02604251 | Completed

• 1 other identifier: CL-K1002-P010
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Surgical Wounds

Outcome Measures

Primary Outcomes (1)

• Adverse Events, Serious Adverse Events and Device Incidents

  Number of patients with adverse events, serious adverse events and device incidents

  24 weeks

Secondary Outcomes (4)

• Patient and Observer Scar Assessment Scale (POSAS)

  up to 24 weeks

• Vancouver Scar Scale (VSS)

  up to 24 weeks

• Efficacy as assessed by blinded experts panel

  up to 24 weeks

• Ease of wound management

  up to 24 weeks

Study Arms (2)

Treatment with KLOX BioPhotonic WoundGel System

EXPERIMENTAL

One breast will be randomized to be treated with KLOX BioPhotonic WoundGel System.

Device: KLOX BioPhotonic WoundGel System

Treatment with silicone sheets

ACTIVE COMPARATOR

The second breast will be randomized to be treated with silicone sheets.

Device: Silicone sheets

Interventions

KLOX BioPhotonic WoundGel System DEVICE

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.

Treatment with KLOX BioPhotonic WoundGel System

Silicone sheets DEVICE

Treatment of the surgical wounds with silicone sheets.

Treatment with silicone sheets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KLOX Technologies Inc.: lead

Study Sites (2)

Victoria Park Medispa

Montreal, Quebec, H3Z1C3, Canada

Location

Westmount Aesthetic Surgery Centre

Montreal, Quebec, H3Z2M5, Canada

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 13, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

CA (2)