Antibiotic Tumescent For Chronic Wounds

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06327113
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non-healing Wound

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CeFAZolin Injectable Solution — DRUG
    One gram Cefazolin reconstituted in 100 mL 0.9% Sodium Chloride (normal saline)

Study Details

Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic wounds in the lower extremities, upper extremities or trunk, will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations.

Key Dates

Start date
May 17, 2024
Status verified
Apr 2026
Primary completion
May 25, 2027
Completion
May 25, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group (Standard Wound Care)
    The 'control' group will receive wound care treatment in accordance to standard of care procedures. The 'control' group will not receive study intervention.
  • Experimental: Treatment Group (Tumescent Antibiotic Injection)
    The 'treatment' group will receive wound care treatment in accordance to standard of care procedures along with the study intervention, a one-time tumescent antibiotic injection (TAI).

Primary Outcome Measure

Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI [ Time Frame: From enrollment through 6 month visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Steven Stokes
[email protected]
310-206-7436
Jenny Lester, MPH
[email protected]
310-794-9728
Andrew Vardanian, MD (PRINCIPAL_INVESTIGATOR)

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