Evaluation of the KLOX BioPhotonic WoundGel System in the Treatment of

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Completed	`NCT01650571` - Evaluation of a 'Hand-Held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (SMH/UHN)	N/A
Completed	`NCT03070925` - Prospective PuraPly™ AM Case Series Study	N/A
Completed	`NCT03286452` - The RESPOND Registry

See also

Status

Clinical Trial

Phase

Completed

NCT01650571 - Evaluation of a 'Hand-Held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (SMH/UHN)

N/A

Completed

NCT03070925 - Prospective PuraPly™ AM Case Series Study

N/A

Completed

NCT03286452 - The RESPOND Registry

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02604251
Study type	Interventional
Source	KLOX Technologies Inc.
Contact
Status	Completed
Phase	N/A
Start date	October 2015
Completion date	November 2017

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms