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

KLOX Technologies Inc.2 sites in 1 country42 target enrollmentOctober 2015

ConditionsSurgical Wounds

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Surgical Wounds
Sponsor: KLOX Technologies Inc.
Enrollment: 42
Locations: 2
Primary Endpoint: Adverse Events, Serious Adverse Events and Device Incidents
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

November 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

KLOX Technologies Inc.

Responsible Party

Sponsor

Eligibility Criteria

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