Dfi clinical Trial Differs from csssi trial

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
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• * 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