BTC6211 Validation and Auditing Clinical Trials

Depika Battu Tosha Dave

Niveditha Mekala Jonali Ramani

Khushboo Surendran Saniya Thosar

Northeastern University November 10, 2015

Wound Dressing For Antimicrobial

Wound Dressing

Guidance Document

Product

Clinical Design

Similarly related drugs and medical devices

Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices

that Include Antimicrobial Agents

• FDA has developed this guidance document to assist industry in preparing premarket notification submissions (510(k)s) for medical devices that include antimicrobial agents

• Antimicrobial agents are substances that kill or inhibit the growth of microorganisms. In certain instances when antimicrobial agents are included on a device, they will be considered drugs2 and the resulting device that includes the antimicrobial drug will be considered a combination product as defined in 21 CFR 3.2(e).

• This guidance is intended for devices containing antimicrobial agents and combination products containing antimicrobial drugs when the primary mode of action is that of a device.

• Drug delivery devices, germicides or sterilants and combination products where the drug component is a new chemical entity (NCE) are not within the scope of this guidance

Clinical Trial of Similar Product:Procellera

Condition Intervention Phase

Acute wounds Other: Procellera™ Antimicrobial DressingOther: Mepilex® Border LiteDevice: Adhesive Bandage

Phase 2

Study Type:

Interventional

Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

 EligibilityInclusion Criteria:If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test.• Wound size greater than 1x1 cm• Wounds must be ≥5 cm away from all other wounds• Wound size must not be diminished in size greater than 10% between

enrollment in study and the prescreening• Participant agrees to participate in follow-up evaluation• Participant must be able to read and understand informed consent, and

sign the informed consent

Criteria EligibilityAges Eligible for Study:   18 Years to 80 Years

Genders Eligible for Study:   Both

Accepts Healthy Volunteers:   No

• Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study

• Participant is to receive another topical antimicrobial agent other than the study dressing

• Participant with sensitivity or adverse reactions to silver or zinc• Pregnancy or nursing an infant or child• Immunosuppression• Active or systemic infection• Peripheral vascular occlusive disease• Collagen vascular disease• Connective tissue disease• Diabetes• Venous stasis ulcers• Participant undergoing active cancer chemotherapy• Chronic steroid use• Decision impairment

Exclusions

Responsible Party: Manager of Clinical Affairs, Vomaris Innovations, Inc.

ClinicalTrials.gov Identifier: NCTO816101  History of Changes   

Other Study ID Numbers: XSMP-002

Study First Received: October 21, 2008

Results First Received: December 13, 2010

Last Updated: March 4, 2011

Health Authority: United States: Institutional Review Board

Sponsor and Collaborators: Vomaris Innovations

Principal Investigator:Scott N Sheftel, MD Sheftel Associates Dermatology

Locations: United States, Arizona Sheftel Associates Dermatology, Tucson, Arizona, United States, 85718

Contacts and Locations

Clinical Trial of Similar Product:Normlgel Ag

Condition Intervention

Chronic Wounds Device: Normlgel Ag

Study Type:

Interventional

Study Design: Allocation: Non Randomized Endpoint Classification: Efficacy Study Intervention Model: Single group Assignment Masking: Open Labeled Primary Purpose: Treatment

Criteria EligibilityAges Eligible for Study:   18 Years or oldGenders Eligible for Study:   Both

Accepts Healthy Volunteers:   No

EligibilityInclusion Criteria:• Signed informed consent• Both genders with an age >18 years• Subjects with chronic wounds < 1 year chronicity that are assessed as

having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection : Erythema, Edema, Warmth ,Increased drainage, Foul odor

• Subject's wounds may also present with:• presence of eschar or slough that needs to be treated prior to normal

standard of care OR• A need for topical care after debridement• Study site to include only ONE wound to be treated

• Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection.

• Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days

• Wound > 1 year old, Wound > 10 cm x 10 cm (l x w), Wound > 6 cm deep

• Use of chemical/enzymatic and biological debridement within 7 days of investigation start

• Necrotizing wounds• Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe

anaemia).• poorly controlled diabetes mellitus.• Subjects treated with systemic glucocorticosteroids, except subjects

taking occasional doses or doses less than 10mg prednisone/day or equivalent.

Exclusions

Responsible Party: Molnlycke Health Care AB.

ClinicalTrials.gov Identifier: NCT01442103  History of Changes   

Other Study ID Numbers: Ng gel 01

Study First Received: September 13, 2013

Last Updated: October 16, 2013

Health Authority: United Kingdom: United States, Institutional Review Board

Sponsor and Collaborators: Molnlycke Health Care AB

Principal Investigator: Zaheed Hasan, MD

Locations: Joseph M. Still Research Foundation, Augusta, Georgia, US.

Contacts and Locations

References:Clinical trial.gov, retrieved from https://clinicaltrials.gov/ct2/show/study/

NCT00816101?term=wound+dressing+for+antimicrobial&rank=1

Clinical trial.gov, retrieved from https://clinicaltrials.gov/ct2/show/NCT01442103?term=wound+infection+hydrogel&rank=3

U.S. Food and Drug Administration (2007), Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents.