Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents

NCT00948519 | Unknown

• 1 other identifier: SLR 09-005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

Chronic rhinosinusitis (CRS) is common disorder which affects up to 13% of the US population. CRS affects numerous Quality of Life (QOL) factors including smell, sleep and communication. The common treatment for medically noncompliant CRS is Functional Endoscopic Sinus Surgery (FESS). As the disease course is generally idle, prolonged medical treatment guidelines are for antibiotic treatment, prescribed accordingly following appropriately obtained nasal cultures, lasting weeks with or without additional topical or oral steroid treatment. While FESS success rate is a general notion, a failure rate of primary FESS is as high as 2-24%2, with a Cochrane review even suggesting that FESS though a safe procedure is of no benefit more than medical management. With that in mind as we address the failed FESS, new bacteria emerge. The new bacteria in CRS are Coagulase-negative staphylococci were the most common isolates (36%), followed by Staphylococcus aureus (25%), Streptococcus viridans (8.3%), Corynebacterium (4.6%), and anaerobes (6.4%). Patients not relieved by primary FESS demonstrate a significant rise in Pseudomonas and MRSA bacteria positive cultures. Moreover surgical success for patients with Staphylococcus aureus and Pseudomonas aeruginosa positive cultures is usually reduced. Bacterial killing, by usage of light-activated agents such as Indocyanine Green (ICG) with exposure to the specific wavelength, eventually produces bacterial killing. Mechanisms primarily involved are production of reactive oxygen species (i.e. singlet oxygen and free radicals) which can then kill bacteria. ICG by itself does not have any bacterial killing effect. Low level laser therapy (LLLT) was shown to be effective as a bactericidal by single and multiple wave exposures. The study purpose is to treat CRS with an alternative to antibiotics, thus sparing volunteers from prolonged antibiotics use and its possible side effects, not to mention the cost and growth of resistant bacteria. We believe that by combining ICG with light or even by light alone we can produce you a beneficial effect. Although this has been shown to kill bacteria in lab or animal studies it is still investigational for humans. The study will have two arms: ICG + laser and laser only arm. ICG will be applied locally in the nasal passage (internally) followed by laser activation with a power setting of 6W. The laser will be activated with a diffuser mode meaning light of a specific known wavelength will be delivered evenly in the nasal cavity and not as a beam. Laser only treatment plan will be the same only without ICG. Volunteers will be assigned to one of the groups randomly meaning you have a 50% chance of enrolling to each treatment group. Volunteers will not know to which group. Weekly visits with a total of three visits will follow. With each visit Volunteers will receive additional treatment as the initial treatment was and a nasal culture will be taken. Volunteers will have to fill a questionnaire with each visit.

Conditions

Rhinosinusitis

Keywords

Rhinosinusitis, sinusitis, chronic, nasal polyps, phototherapy, laser,laser therapy, antibiotic, safety laser, ICG, indocyanine green; Chronic Rhinosinusitis with or without nasal polyposis

Outcome Measures

Primary Outcomes (1)

• Quality of Life improvement with disease control. Disease control without antibiotics or steroids.

  1-2 months

Secondary Outcomes (1)

• Laser safety without compromising disease progress

  immediate and late

Study Arms (2)

Laser + ICG

EXPERIMENTAL

ICG arm- will be defined as local application on a pledget soaked with ICG with a concentration of 200µg, upon removal of the pledget a NIR diode laser set at 6W with light emittance introduced intranasally with a 30mm diffuser fiber capable of radiating light circumferentially allowing the light energy to reach all treatable areas. Laser will be activated for 180 seconds. Assuming an approximate radius of the nasal cavity is 3mm, energy density will be around 200J/cm². Treatment will be repeated twice, 5-7 day apart. Cultures will be collected at the end of all treatments

Device: Laser + ICG

Laser only

ACTIVE COMPARATOR

same as above, without ICG

Device: Laser only

Interventions

Laser + ICG DEVICE

ICG arm- will be defined as local application on a pledget soaked with ICG with a concentration of 200µg, upon removal of the pledget a NIR diode laser set at 6W with light emittance introduced intranasally with a 30mm diffuser fiber capable of radiating light circumferentially allowing the light energy to reach all treatable areas. Laser will be activated for 180 seconds. Assuming an approximate radius of the nasal cavity is 3mm, energy density will be around 200J/cm². Treatment will be repeated twice, 5-7 day apart. Cultures will be collected at the end of all treatments

Laser + ICG

Laser only DEVICE

same only without ICG

Laser only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18
• Patients with an established nasal culture of either
• Staph aureus,
• Strep species,
• Pseudo monasaureginosa,
• Proteus.mirabilis,
• H. influenza
• or other intranasal pathogens.

You may not qualify if:

• Patients without CRS,
• Patients known to have Iodide allergy or ICG allergy
• Patients scheduled for a thyroid scan
• Pregnant or breastfeeding.

Sponsors & Collaborators

• New York Head & Neck Institute: lead
• Valam Corp.: collaborator

Study Sites (3)

St.Luke's-Roosevelt, New York Head Neck Institute

New York, New York, 10019, United States

RECRUITING

Head Neck Surgical Group

New York, New York, 10022, United States

RECRUITING

New York Head Neck Institute

New York, New York, United States

RECRUITING

Related Publications (2)

• Omar GS, Wilson M, Nair SP. Lethal photosensitization of wound-associated microbes using indocyanine green and near-infrared light. BMC Microbiol. 2008 Jul 1;8:111. doi: 10.1186/1471-2180-8-111.

  PMID: 18593460 BACKGROUND

• Guffey JS, Wilborn J. Effects of combined 405-nm and 880-nm light on Staphylococcus aureus and Pseudomonas aeruginosa in vitro. Photomed Laser Surg. 2006 Dec;24(6):680-3. doi: 10.1089/pho.2006.24.680.

  PMID: 17199465 BACKGROUND

MeSH Terms

Conditions

Rhinosinusitis; Sinusitis; Bronchiolitis Obliterans Syndrome; Nasal Polyps

Interventions

Lasers

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Yosef Krespi, MD

CONTACT

12122624444; hnsg@aol.com

Victor Kizhner, MD

CONTACT

vkizhner@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 22, 2011

Record last verified: 2009-07

Locations

US (3)