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Clinical trial design on wound dressing for antimicrobial

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Clinical trial design on wound dressing for antimicrobial

  1. 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. 2. Wound Dressing For Antimicrobial Guidance Document Product Clinical Design Similarly related drugs and medical devices
  3. 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 Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents • FDA has developed this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. 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. 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. 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. 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. 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. 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. 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. 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. 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.

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