Dfi clinical Trial Differs from csssi trial



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Curretage of wound base

  • after cleansing/debriding scrape with scalpel
  • send tissue on blade in sterile container
  • Tissue specimens: obtain at bedside/OR

  • Aspiration: for secretions, cellulitis



  • Wound Scoring System

    • Designed to give objective wound score

    • Includes quantified

      • General wound parameters (description)
      • Peripheral pulses assessment
      • Wound measurements
      • Wound infection score


    Probe to Bone

    • One study* in 76 patients:

      • Sensitivity 66%; Specificity 85%
      • + Predict. value 89%; - Predict. value 56%
    • Technique: 14 cm 5 F sterile metal probe

      • Done prior to wound debridement (x eschar)
      • Use routine aseptic procedures; clinic/bedside
      • Holding like pencil, gently probe wound
      • Hard, gritty structure in wound, w/o apparent intervening soft tissue, is + test
      • Avoid if closed/surgically exposed wounds
      • -------------------------------------------------------------
    • * Grayson et al, JAMA 1995;273:721-3



    Treatment

    • Drug vs. comparator (gold standard) – IV or PO

    • Can add other agents for activity against organisms not covered by the study drug

    • 7 – 21 days of antibiotics; 14 days is usual duration



    Adjunctive Therapy

    • Debridement/surgery

    • Dressing changes

    • Off-loading

    • Not allowed: topical antibiotic, anti-septic, or other antimicrobial agents (i.e., Betadine)



    Topical Therapy

    • Antimicrobials

      • No topical antibiotics (mupirocin, sulfa, aminoglycosides, etc.)
      • No topical antiseptics (H2O2, iodophors, chlorhexidine, silver, etc.)
    • Others (non-antimicrobial)

      • Agents such as becaplermin, collagen, etc. are allowed, but not encouraged


    Wound Dressings

    • Many available types- none proven best

    • Moist environment preferred

    • No antimicrobial products allowed

    • Moist-to-damp saline dressing adequate

    • Other types permissible



    Wound Off-Loading

    • Helpful to curing infection and crucial healing wound

    • Many devices used- none proven best

      • total contact cast
      • special shoes/boots
      • crutches, wheelchair, etc


    Efficacy Evaluations (1)

    • Follow-up for test-of-cure at 14 – 21 days after end of therapy

    • Clinical response to therapy – defined as resolution of pre-therapy clinical signs and symptoms of infection

    • Final categories: cured, failed, indeterminate



    Efficacy Evaluations (2)

    • Surgical debridement is allowed during the trial and is considered part of standard care

    • Complete resection of the infected area will remove patient from the trial



    Sample Size

    • Assume 80% success rate for comparator

    • Difference in cure rate of <10% will be considered equivalent

    • ?Criteria for superiority



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