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Antibiotic Tumescent Injections for Chronic Wounds

This study is looking at a new way to treat chronic, non-healing wounds using an antibiotic called Cefazolin. Researchers will inject a solution of Cefazolin around the wound. The study aims to see how safe this treatment is by tracking any side effects and how severe they are. You could be eligible if you are an adult (18 or older) with a chronic wound on your arm, leg, or body (not hands) that is between 0.5 cm² and 30 cm² in size. The study plans to enroll 60 people. All participants will continue to receive standard wound care. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with an unclear phase, planning to enroll 60 participants. Participants will either continue standard care or be randomized to receive antibiotic injections.
What's involved
You would have approximately 6 study visits over about 6 months. During these visits, wound size and healing will be documented, and you will complete surveys.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment through a 6-month visit to assess adverse events.

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NCT06327113

Antibiotic Tumescent For Chronic Wounds

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, Los Angeles
~60 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:CeFAZolin Injectable Solution

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI
Measured over From enrollment through 6 month visit.

Conditions

Non-healing Wound

Explore related trials

Chronic wound

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Seth Putterman, PhD · STUDY_DIRECTOR · University of California, Los Angeles

Who to contact

Andrew Vardanian, MD
[email protected]
310-825-8927
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female ≥18 years of age.
Must have:
Adequate perfusion as demonstrated by TcPO2≥40 mm Hg, ABI ≥ 0.7, or great toe pressure≥50 mm Hg, or palpable pulses of the lower extremity such as dorsalis pedis and/or posterior tibial artery or palpable radial artery in the upper extremity.
In the opinion of the investigator, participants must be considered reliable, willing, and able to give signed informed consent in English and sign the informed consent form.
For participants of reproductive potential, two of the following forms of contraception are required between visits 1-4 (total of 3-6 weeks), one of which must be a barrier method:
Cellulitis or acute infection as determined by:
Following enrollment, if wound culture returns positive for Pseudomonas.
Participants with symptoms of systemic infection or uncontrolled diabetes mellitus (e.g., severe hyperglycemia, ketoacidosis, azotemia).
Participants who are allergic or have shown hypersensitivity to penicillin, cefazolin, other beta-lactams, the cephalosporin group of antibiotics, lidocaine, or to local anesthetics of the amide type.
Participants requiring intravenous antimicrobials during the study period for any infection, including diabetic foot ulcer. Mild localized infection that would be treated on an outpatient basis could be approved by Medical Director authorization.
Participants who are currently treated by dialysis, awaiting dialysis, or who have an estimated glomerular filtration rate of ≤ 30 mL/min/1.73 m\^2.
Participants who are expected to be unable to care for their ulcer because of hospitalization, vacation, disability, etc., during the study period.
Participants with known active alcohol or substance abuse within the 6 months preceding study entry.
Participants who are receiving systemic corticosteroids (in a dose equivalent to ≥20 mg of prednisone per day), biologic therapy, immunosuppressants, , radiation therapy, or cytotoxic agents, unless approved by medical director authorization
Participants who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin, not involving the wound site).
Participants with acquired immune deficiency syndrome (AIDS) or known human immunodeficiency virus (HIV) positivity.
Participants with other conditions considered by the investigator to be reasons for disqualification that may jeopardize participant safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
Women who are breastfeeding, pregnant, or attempting to become pregnant.
Active acute medically unstable condition defined by:
Participant is enrolled/participating in another study or does not agree to refrain from participating in another study while enrolled in this study.

Exclusion

Participants with limb threatening infection, extensive cellulitis (≥2 cm radially beyond the borders of the wound), lymphangitis, fasciitis, deep tissue infection, abscess, pus, osteomyelitis, or other evidence of local or systemic complications of infection.

What this trial measures

  • Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAIFrom enrollment through 6 month visit.

    Adverse events will be tabulated by treatment group and will include the number of participants for whom the event occurred, the rate of occurrence, and the relationship to TAI. The severity of adverse events will be measured by the adverse event severity scale (1-4; Mild; Moderate; Severe; Life-threatening). The relationship of the adverse event to the study drug will be assessed by the likelihood of the relationship (Definitely; Probably; Possibly; Unrelated). Frequency of adverse events that result in discontinuation of the investigative treatment will be quantified.