1. BTC6211 Validation and Auditing
Clinical Trials
Depika Battu
Tosha Dave
Niveditha Mekala
Jonali Ramani
Khushboo Surendran
Saniya Thosar
Northeastern University
November 10, 2015

2. Wound Dressing For Antimicrobial
Guidance Document
Product
Clinical
Design
Similarly related drugs
and medical devices

3. Draft Guidance for Industry and FDA Staff - Premarket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

4. Clinical Trial of Similar Product:
Procellera
Condition Intervention Phase
Acute wounds Other:
Procellera™ Antimicrobial
Dressing
Other: Mepilex® Border
Lite
Device: 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

5. Eligibility
Inclusion 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 Eligibility
Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

6. • 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

7. 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

8. 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

9. Criteria Eligibility
Ages Eligible for Study: 18 Years or old
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Eligibility
Inclusion 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

10. • 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

11. 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

12. 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+hydr
ogel&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.